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The hospital failed to ensure the Condition of Participation: CFR 482.12 Governing Body was met by failing to:1. Ensure there was a system to identify unsanitary conditions (mold/spores)in one of the walk-in refrigerators in the kitchen when kitchen staff did not clean the refrigerator in a manner to prevent overgrowth of mold on several insulation pipes in the hospital kitchen. Mold/ Sores had the potential to contaminate all food items stored in the walk-in refrigerator serving staff, visitors and hospitalized patients in a universe of 174 patients. (Refer to A-0749)On July 7, 2015 at 5:59 PM, Immediate Jeopardy #1 was called in the presence of the facility Chief Nursing Officer, Director of Quality Management, Director of Infection Control and Vice President of Support/Clinical Services due to the hospital's failure to ensure that there was a system to identify unsanitary conditions in one of the walk-in refrigerators in the hospital kitchen. (Refer to A-0749).


On July 8, 2015 at 4:10 PM, the Immediate Jeopardy was abated in the presence of the facility's Vice President Medical Affairs, the Vice President Chief Operating Officer, the Vice President Chief Nursing Officer, the Vice President Support/Clinical Services, and the Director of Quality Management after an acceptable corrective action plan was presented, validated, and approved, by the survey team.
2. Ensure that the dietetic service department was organized and staffed in a manner that ensured the needs of the patients were met. (Refer A-0622, A-0701, A-0724, A-0749).


3 The Governing Body failed to ensure the quality of the contracted transcription services, were followed according to hospital policy and procedure which had the potential to increase the risk of substandard healthcare for all hospital patients in a universe of 174 patients. (Refer A-0084)

4. The Governing Body did not ensure that the transcription service was included on the master list of contracted services. This practice had the potential to increase the risk of poor quality transcription of all facility patient's medical records serviced by the hospital. (Refer A-0085)


5. Ensure that the hospital's emergency preparedness plan was to be able to shelter in place 4 days. This plan included the use of perishable food for the first 2 days and a dehydrated meal plan for the second phase. (Refer A-0701).

6.. Ensure the correct dosage of Potassium Chloride IVPBs was stored (Intravenous Piggy Bags) were dispensed in the Omnicell ADC (Automated Dispensing Machine used to store and dispense medication.) (Refer to A 0491).On July 9, 2015 at 10:24 AM, Immediate Jeopardy #2 was called in the presence of Vice President Medical Affairs, Vice President Chief Operating Officer, Vice President Chief Nursing Officer, Vice President Support/Clinical Services, and the Director of Quality Management due to hospital's failure to ensure that the correct dosage of Potassium Chloride was stored in the Omnicell ADC (An automated dispensing machine used to store and dispense medication.) (Refer to A 0491)

On July 9, 2015 at 5:59 PM, Immediate Jeopardy #2 was abated in the presence of the Vice President Medical Affairs, Vice President Chief Operating Officer, Vice President Chief Nursing Officer, Vice President Support/Clinical Services, and the Director of Quality Management after an acceptable corrective action plan was presented, validated, and approved, by the survey team.
7. Ensure medications were properly stored and secured, policies and procedures were implemented for controlled medication and compounded sterile medications. (Refer to A 0491).

8. Ensure medications were appropriately labeled with the appropriate beyond-use-date (BUD) according to manufacturer's specifications and facility's policies. As a result, there was a potential for the medication to be administered after the BUD had passed. (Refer to A 0501).
9. sure that the medical staff provided an accurate, complete and scientific patient medical record for two patients (Patient 1 and Patient 10). This practice increased the risk of substandard medical care for all facility patients.(Refer to A 0353)10. Follow policy and procedures for patient's self-administration of medication, for one (1) of 56 sampled patients. Patient 47 applied the Ketoconazole (Nizoral) cream by himself when there was no physician order to allow this practice, and the facility did not assess the patient's capacity for self-administration of medication.(A 0412)11. Ensure multiple physician telephone orders were signed/authenticated within 48 hours by the ordering physician, for 2 out of 57sampled patients (Patient 5 and Patient 29). This failure of not signing/authenticating physician telephone orders had the potential to adversely affect the overall health and safety of the patients.(Refer to A 0454)12. Ensure a history and physical assessment was completed, documented, and placed into the patient's clinical record, within the required 24 hours after admission to the facility, for one of 56 sampled patients (Patient #3). This failure placed the patient at risk for not receiving the appropriate treatment and plan of care, based on the patient's current and historical health condition(s).(Refer A 0458)13. Ensure that its staff accurately documented the care provided to one sampled patient (Patient 25). Two nurses (RN 4 and RN16) documented in the Patient's 25 clinical record that medications, one for the treatment for a pressure ulcer and the other was an intravenous medication was given when it was not. Nurses responsible for the care of Patient 25 did not accurately document the condition of the pressure ulcer. and effectiveness of care. (Refer to A 0467)

The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in a safe manner in order to be in compliance with the Condition of Participation: Governing Body.

Based on interview and record review, the Governing Body failed to ensure the quality of the contracted transcription services, were followed according to hospital policy and procedure which had the potentila to increase the risk of substandard healthcare for all hospital patients in a universe of 174 patients.

Findings:

On Juky 6, 2015, a review of the clinical record for Patient 1, revealed in the Consultation Note, dated July 5, 2015, noted "I started seeing him on July 5, 2015, it looks like it is July 6, 2015 now, time just flies when you are having fun."

During a review of the clinical record for Patient 10, the Procedure Note, electronically signed on June 16, 2015, did not indicate the date after "Date of Procedure" and did not indicate the Preoperative Diagnosis (reason for procedure) or the Postoperative Diagnosis (results of the procedure), as they were both left blank. Review of the Discharge Summary (summary of hospital events), electronically signed on June 3, 2015, indicated "Date of Admission: May 29, 2015 but did not indicate the date after "Date of Discharge" (date patient left the hospital) as it was left blank.

During an interview with the DMS (Director Medical Staff), on July 9, 2015, at 7:40 AM, he reviewed the clinical record for Patient 1, including the Consultation Note, dated July 5, 2015. When he was asked about the quote "time just flies when you are having fun," which appeared in the patient's Consultation note, DMS stated "I don't know if anyone is checking quality of the dictated notes."

During an interview with the DOQ (Director of Quality) on July 9, 2015, at 4:05 PM, the DOQ reviewed the evaluation of contracted services (quality information about services provided to patients by an outside company). The DOQ was asked about the evaluation (of the quality) of the transcription service (the service that types up the doctors' dictated patient notes), The DOQ was unable to find documentation of a quality evaluation of the contracted service. The DOQ also reviewed the entire list of contracted services provided and was unable to find documentation of the transcription service on the list. The DOQ then explained "We don't do them all."

The facility document titled "Amended and Restated Bylaws of the (name of facility) Hospital Community Board," dated April 2, 2007, indicated "The hospital community board is responsible for assuring that health care services at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for ongoing quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital ..."

Based on interview and record review, the facility's governing body did not ensure that the transcription service was included on the master list of contracted services. This practice had the potential to increase the risk of poor quality transcription of all facility patient's medical records in a universe of 174 patients.

Findings:

During a review of the clinical record for Patient 1, the Consultation Note, dated July 5, 2015, indicated "I started seeing him on July 5, 2015, it looks like it is July 6, 2015 now, time just flies when you are having fun."

During a review of the clinical record for Patient 10, the Procedure Note, electronically signed on June 16, 2015, did not indicate the date after "Date of Procedure" and did not indicate the Preoperative Diagnosis (reason for procedure) or the Postoperative Diagnosis (results of the procedure), as they were both left blank. Review of the Discharge Summary (summary of hospital events), electronically signed on June 3, 2015, indicated "Date of Admission: May 29, 2015 but did not indicate the date after "Date of Discharge" (date patient left the hospital) as it was left blank.

During an interview with DMS (Director Medical Staff), on July 9, 2015, at 7:40 AM, he reviewed the clinical record for Patient #1, including the Consultation Note, dated July 5, 2015. When he was asked about the quote "time just flies when you are having fun", which appeared in the patient's Consultation note, which is part of the permanent patient clinical record, he answered "I don't know if anyone is checking quality of the dictated notes."

During an interview with the DOQ on July 9, 2015, at 4:05 PM, she reviewed the evaluation of contracted services (quality information about services provided to patients by an outside company). When the DOQ was asked about the evaluation (of the quality) of the transcription service (the service that types up the doctors' dictated patient notes) for the Governing Board, DOQ was unable to find documentation of a quality control evaluation of the contracted service. The DOQ also reviewed the entire list of contracted services provided and was unable to find documentation of the transcription service on the master list. The DOQ then explained "We don't do them all."

The facility document titled "Amended and Restated Bylaws of the (name of facility) Hospital Community Board," dated April 2, 2007, indicated "The hospital community board is responsible for assuring that health care services at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for ongoing quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital ..."

The facility did not have the transcription service on their master list for all contracted services provided by the hospital as required.

The hospital failed to ensure the Condition of Participation: CFR 482.21 Quality Assurance and Performance Improvement was met by falling to:1. Ensure there was a system to identify unsanitary conditions in one of the walk-in refrigerators in the kitchen when kitchen staff did not clean the refrigerator in a manner to prevent overgrowth of mold/spores on several insulation pipes. (Refer to A-0749)On July 7, 2015 at 5:59 PM, Immediate Jeopardy #1 was called in the presence of the facility Chief Nursing Officer, Director of Quality Management, Director of Infection Control and Vice President of Support/Clinical Services due to the hospital's failure to ensure that there was a system to identify unsanitary conditions in one of the walk-in refrigerators in the kitchen. (Refer to A-0749).

On July 8, 2015 at 4:10 PM, the Immediate Jeopardy was abated in the presence of the facility's Vice President Medical Affairs, the Vice President Chief Operating Officer, the Vice President Chief Nursing Officer, the Vice President Support/Clinical Services, and the Director of Quality Management after an acceptable corrective action plan was presented, validated, and approved, by the survey team. (Refer A-0620, A-0622)

2. Ensure that the dietetic service department was organized and staffed in a manner that ensured the needs of the patients were met. Deficient practices were observed in areas of staff training, kitchen sanitation, equipment maintenance, meal preparation and infection control practices. These failures had the potential to affect all admitted patients that received meals from the kitchen, staff and visitors that purchased food from the cafeteria. (Refer A-0622, A-0701, A-0724, A-0749).

3. Ensure that three dietary staff (KS1, FSW 4 and FSW 5) was able to properly test the chemical sanitizer in the sanitizing bucket. None of the employees immersed the test strip for the recommended (by the manufacturer) time of 10 seconds on the label. Immersion times varied form 5 seconds to 15 seconds. The Food Service Director (FSD 1) stated in an interview on 07/08/15 at 8:50 am that the former director (FSD 2) had provided training and laminated instructions as tools to help staff in testing the sanitizer correctly. Review of facility document titled " Cleaning and Sanitizing "dated" Feb. 2015" revealed two of the three dietary staff attended the training. (Refer A-0622).

4. Ensure that the hospital's emergency preparedness plan was to be able to shelter (be in place) in place for 4 days. This plan included the use of perishable food for the first 2 days and a dehydrated meal plan for the second phase. During the survey, the hospital experienced a power outage; the refrigerators and freezer were unable to maintain temperatures because it was not connected to the emergency power source resulting in some foods being stored in the food danger zone (temperatures between 41 and 135 degrees Fahrenheit). In a true emergency, the failure of the refrigerator and freezer could have resulted in inadequate food for the patients and staff. (Refer A-0701).
5. Ensure the correct dosage of Potassium Chloride IVPBs was stored (Intravenous Piggy Bags) were dispensed in the Omnicell ADC (Automated Dispensing Machine used to store and dispense medication.) (Refer to A 0491).On July 9, 2015 at 10:24 AM, Immediate Jeopardy #2 was called in the presence of Vice President Medical Affairs, Vice President Chief Operating Officer, Vice President Chief Nursing Officer, Vice President Support/Clinical Services, and the Director of Quality Management due to hospital's failure to ensure that the correct dosage of Potassium Chloride was stored in the Omnicell ADC (An automated dispensing machine used to store and dispense medication.) (Refer to A 0491)

On July 9, 2015 at 5:59 PM, Immediate Jeopardy #2 was abated in the presence of the Vice President Medical Affairs, Vice President Chief Operating Officer, Vice President Chief Nursing Officer, Vice President Support/Clinical Services, and the Director of Quality Management after an acceptable corrective action plan was presented, validated, and approved, by the survey team.
6. Ensure medications were properly stored and secured, policies and procedures were implemented for controlled medication and compounded sterile medications. (Refer to A 0491).


7. Based on interview and record review, the hospital did not ensure that findings from quality assurance activities were used to identify multiple opportunities for improvement. The facility failed to identify: a. The wrong dosage of Potassium Chloride was stored in the Omnicell ADC (An automated dispensing machine used to store and dispense medication.) in the Telemetry Overflow Unit ).b. The walk-in refrigerator in the dietary kitchen was not cleaned on a regular basis and kept free of mold.c. The patient 7 did not receive adequate post-operative care including evaluation of wound drainage prior to hospital discharge.d. A laryngoscope blade (instrument used to obtain a view of the vocal cords) was available for patient use, in the Operating Room (OR) after the packaging had become compromised.e. A partially used, undated bottle of sterile water was left in the OR after the surgical procedure was completed and after the OR was cleaned for the next patient.

f. The OR table pad was intact and easy to disinfect after each patient.g. Medical Staff dictated patient medical record notes that were complete.8. Based on observation, document review and interview, the facility failed to ensure a safe environment for their patients from fire. This was evidenced by not providing a reliable emergency back-up power to continuously supply electricity to their critical Life Safety Systems and failed to provide continuous illumination to their path of egress to ensure a safe evacuation. (A 0710).

The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in a safe setting in order to be in compliance with the Condition of Participation for Quality Assurance and Performance Improvement.

Based on interview and record review, the hospital did not ensure that findings from quality assurance activities were used to identify multiple opportunities for improvement. The facility failed to identify: :1. The wrong dosage of Potassium Chloride was stored in the Omnicell ADC (An automated dispensing machine used to store and dispense medication.) in the Telemetry Overflow Unit ).2. The walk-in refrigerator in the dietary kitchen was not cleaned on a regular basis and kept free of mold.3. Patient 7 did not receive adequate post-operative care including evaluation of wound drainage prior to hospital discharge.4. A laryngoscope blade (instrument used to obtain a view of the vocal cords) was available for patient use, in the Operating Room (OR) afer the packaging had become compromised.5. A partially used, undated bottle of sterile water was left in the OR after the surgical procedure was completed and after the OR was cleaned for the next patient.

6. The OR table pad was intact and easy to disinfect after each patient.7. Medical Staff dictated patient medical record notes that wre complete.These deficinet practices increased the risk of substandard care for all hospital patients, in a universe of 174 patients

Findings:

1(a). The medication storage area on 4 Tower North, a telemetry unit, was inspected at 9:25 AM on July 8, 2015 with the Director of Pharmacy (DOP) and Pharmacy Technician Supervisor (Tech 1). Five (5) units of KCl 20 mEq in 100 mL solution was stocked in the ADC location designated for KCl 10 mEq in 100 mL solution.

Tech 1 stated KCl was a "high-alert" medication, would require a "double check," and was checked by the pharmacist to ensure accuracy before leaving the pharmacy. The pharmacy technician then would select the medication to be restocked on the ADC screen. The light on the ADC's bin would light up to guide the technician to the correct bin to restock the medication.

According to the facility's policy titled, "Nursing Unit Inspections," effective date 4/79, Policy section, "Each nursing care unit ... where medications are dispensed, administered, or stored, should be inspected at least monthly by the pharmacist." In the Procedures section, "... the Pharmacist will verify that: ...(d) Proper stock medications are available ... Automated Dispensing Machines (ADC) are spot-checked for accuracy and expiration."

According to the ADC's transaction record provided by the facility, five (5) units of KCl 10 mEq in 100 mL were stocked in the ADC on April 8, 2015 by Pharmacy Technician (Tech 3). On June 3, 2015, Pharmacist 1 (RPh 1) inspected the storage for KCl 10 mEq in 100 mL in the ADC, but did not discover the inaccuracy.

1(b). During a inspection of the Post Anesthesia Care Unit (Recovery Room) Omnicell ADC on July 9, 2015, at 8 AM, Registered Nurse 6 (RN 6) was asked to locate and retrieve a potassium chloride (KCL) 20mEq in 100mL injection from the ADC. RN 6 utilized the ADC controls to request the KCL 20mEq and a tray near the bottom of the ADC opened. In the tray were 10 pockets or areas where individual medications could be stored. KCL 20mEq was located in the 3rd pocket from the left in the top row. Two pockets to the left in the same row was KCL 10mEq in 100mL injection. It was noted that a green flashing light that is located on each pocket of the tray, to indicate to the nurse where the medication is located, was not flashing. When asked what happened to the light, RN 6 stated, "The light is missing." When asked if it was possible for a nurse to take KCL 10mEq injection instead of KCL 20mEq injection due to being close and no flashing light to indicate which medication to pull out, RN 6 stated, "Yeah, if they aren't checking."

On July 9, 2015 at 10:24 AM, Immediate Jeopardy #2 was called in the presence of Vice President Medical Affairs, Vice President Chief Operating Officer, Vice President Chief Nursing Officer, Vice President Support/Clinical Services, and the Director of Quality Management due to hospital's failure to ensure that the correct dosage of Potassium Chloride was stored in the Omnicell ADC.

On July 9, 2015 at 5:59 PM, Immediate Jeopardy #2 was abated in the presence of the Vice President Medical Affairs, Vice President Chief Operating Officer, Vice President Chief Nursing Officer, Vice President Support/Clinical Services, and the Director of Quality Management after an acceptable corrective action plan was presented, validated, and approved, by the survey team.

2. During the inspection of the kitchen on July 6, 2015 at approximately 9:45 AM, there was a strong musty smell inside the walk -in refrigerator. The dimly lit refrigerator was inspected using a flash light. Underneath the condenser, there were several pipes covered with black insulation. Inspection revealed the presence of white and black colored substance (fungus/mold) on different areas of all of the pipe insulation. More of the black colored mold was observed on the walls and floor of the refrigerator. The presence of mold was validated by laboratory analysis.

Food service director (FSD) was present during this observation. The FSD stated on July 7, 2015 at 9:45 AM the refrigerator was called the "Cook's refrigerator." The FSD stated in the concurrent interview that the Food service Supervisor (EC) was responsible for ensuring the sanitation of the refrigerator. EC was interviewed at 9:50 AM on July 7, 2015. EC stated that the refrigerator was cleaned daily. He presented a copy of a document titled "Master Cleaning Schedule" to show that the refrigerator was being cleaned. Review of the document at 10:00 AM showed that the schedule did not include this refrigerator by its name.

The Executive Chef (EC) stated that the refrigerator was cleaned daily even if it did not list it by name on the schedule. The document further showed the last time the areas listed on the cleaning schedule as being cleaned was on " 5/6 ", two months before, validated by the presence of an initial. EC stated that the refrigerator did not have any problems with temperatures. A review of the temperature log for the month did not reveal any temperature discrepancies. The temperature of the refrigerator on July 7, 2015 at 10:00 AM was 47.6 degrees Fahrenheit. The recommended temperature for a refrigerator is below 41 degrees Fahrenheit. Mold grows at all temperatures including 32 to 95 degrees Fahrenheitt to thrive at 77 to 86 degrees Fahrenheit. The EC and FSD did not provide any information on why the refrigerator was not cleaned as scheduled or why no one noticed the overgrowth of mold.

3. During a review of the clinical record for Patient 7, the History and Physical, dated February 18, 2015, indicated " Masses in bilateral (both sides) breasts,? etiology (unknown cause) ...Recommendation Bilateral Breast ...Biopsy (removal of tissue for analysis). " The Operative Note, dated February 19, 2015, indicated " Title of operation: Bilateral breast needle localization (to mark the area to be removed and analyzed) with bilateral lumpectomy (removal of tissue for analysis) ...We then came to the left side, and similarly incision was made ...Because of the large cavity, a #7 JP (Jackson Pratt) drain (to allow fluid to drain from the surgical site) was left ... "The Post Anesthesia Care Unit (PACU) record, dated February 19, 2015, indicated no documented evidence that the output (amount of fluid that drained out of the surgical wound) from the JP drain was assessed by the nursing staff before Patient 7 was discharged home.

During an interview with RN Unit Director 1, on July 8, 2015, at 8:55 AM, she reviewed the clinical record for Patient 7 and was unable to find documentation of the output from the JP drain before Patient 7 was discharged home. RN Unit Director 1 agreed that it was important for the nursing staff to have evaluated and documented the fluid drainage from the surgical wound (JP drain) before Patient 7 was discharged home. The RN Unit Director 1 confirmed that no causal analysis was performed regarding the post-operative care of
Patient 7.

During a review of the clinical record for Patient 7, the Emergency Department Chart, dated February 20, 2015, indicated "Diagnosis Left Breast Pain." The Operative Note, dated February 20, 2015, (for the second operation) indicated "Preoperative Diagnosis Left breast hematoma (a solid swelling of clotted blood within the tissues) post lumpectomy (after breast tissue removal surgery) ...A fairly large hematoma evacuated (removed) with the removing the large amount of blood clots that appeared to be close to about one unit (of blood) by gross estimation ...A #19 Blake drain (to allow fluid to drain from the surgical site) was inserted ..."

During an interview with RN Unit Director 1, on July 8, 2015, at 8:55 AM, she reviewed the clinical record for Patient 7 and confirmed that Patient 7 returned to the facility Emergency Department one day after her surgery complaining of pain. She also confirmed that Patient 7 had to have a second surgery to remove a large quantity of blood that had accumulated in the surgical wound overnight.

The facility policy and procedure titled "Scopes of Services Post Anesthesia Care Unit" dated September 2014, indicated " As a division of Perioperative Services (services around surgery), it provides comprehensive immediate post-operative and post-procedural nursing care for inpatients and outpatients who have received general, regional and procedural sedation (medication to decrease pain and awareness during surgery) ...Qualifications and Responsibilities of Staff ...Registered Nurse ...Document clearly and concisely all aspects of care provided. "

4. During an observation on July 6, 2015, at 9:45 AM, in Operating Room (OR) 4, a short blade of a laryngoscope (instrument used to obtain a view of the vocal cords) was observed, wrapped in a sterile package that had a yellow water stain. This packaged equipment was stored in OR 4 and available for patient use. During a concurrent interview with RN Unit Director 1, she acknowledged the yellow stained packaged instrument and removed it from OR 4 to be re-sterilized.The facility policy and procedure titled, "Scopes of Services Post Anesthesia Care Unit" dated September 2014, indicated "Recognized Standards OR Practice Guidelines. Association of Perioperative Registered Nurse (AORN)."AORN Recommended Practices for Sterilization, Recommendation XV.a, dated 2013, indicated "The shelf life of a packaged sterile item should be considered event-related. Shelf life is dependent on packaging material, storage conditions, transport, and handling. An event must occur to compromise package content sterility. Events that may compromise the sterility of a package include...moisture penetration..."

5. During an observation on July 6, 2015, at 9:45 AM, in Operating Room (OR.) 4, a one liter bottle of sterile water was observed to be open undated and three-quarters empty. The bottle was found in OR 4 after the room had been cleaned in preparation for the next patient surgery. During a concurrent interview with RN Unit Director 1, she acknowledged the opened, undated and used bottle of sterile water and agreed that it should be removed from the OR.

The facility policy and procedure titled "Medication Administration to Sterile Field " dated January 2015, indicated "All medication containers on/off sterile field will be kept in the O.R. Suite until conclusion of procedure."

6. During an observation on July 6, 2015, at 9:45 AM, in Operating Room (OR.) 4, the O.R. table was observed to have multiple one inch tears, in the O.R. table pad, where the patient is located during surgery. During a concurrent interview with RN Unit Director 1, she acknowledged the tears and quickly replaced the pad with a different, intact pad that would be easier to keep clean.

The facility policy and procedure titled "Scopes of Services Post Anesthesia Care Unit" dated September 2014, indicated "Recognized Standards OR Practice Guidelines. Association of Perioperative Registered Nurse (AORN). "

According to AORN, "Recommended Practices for Environmental Cleaning in the Perioperative Setting, Recommendation I: The Patient should be provided a clean, safe environment. Exogenous sources for pathogens that may cause a surgical site infection (SSI) include surgical personnel; the operating room environment (including the air); and all tools, instruments, and supplies brought to the sterile field during the procedure. Exogenous flora are mainly aerobes. Health care-associated infections have been linked to external sources, which can include environmental surfaces. The risk of infection from pathogenic organisms on environmental surfaces is due not only to their presence, but to their ability to survive on and be transferred to many surfaces."

7. During a review of the clinical record for Patient 1, the Consultation Note, dated July 5, 2015, indicated " I started seeing him on July 5, 2015, it looks like it is July 6, 2015 now, time just flies when you are having fun. "

During a review of the clinical record for Patient 10, the Procedure Note, electronically signed on June 16, 2015, did not indicate the date after "Date of Procedure" and did not indicate the Preoperative Diagnosis (reason for procedure) or the Postoperative Diagnosis (results of the procedure), as they were both left blank. Review of the Discharge Summary (summary of hospital events), electronically signed on June 3, 2015, indicated "Date of Admission: May 29, 2015" but did not indicate the date after "Date of Discharge" (date patient left the hospital) as it was left blank.

During an interview with Director of Medical Staff (DMS), on July 9, 2015, at 7:40 AM, he reviewed the clinical record for Patient #1, including the Consultation Note, dated July 5, 2015. When he was asked about the quote " time just flies when you are having fun," which appeared in the patient's Consultation note, which is part of the permanent patient clinical record, he answered "I don't know if anyone is checking quality of the dictated notes."

During an interview with the DOQ on July 9, 2015, at 4:05 PM, she reviewed the evaluation of contracted services (quality information about services provided to patients by an outside company). When the DOQ was asked about the evaluation (of the quality) of the transcription service (the service that types up the doctors ' dictated patient notes) for the Governing Board, DOQ was unable to find documentation of a quality control evaluation of the contracted service. The DOQ also reviewed the entire master list of contracted services provided and was unable to find documentation of the transcription service on the list. The DOQ then explained "We don't do them all. "

The hospital Medical Staff Bylaws, dated December 2014, indicated "The attending Practitioner shall be held responsible for the preparation of a complete medical record of each patient... No medical record shall be filed until it is complete... the attending Practitioner is responsible for furnishing a complete, accurate and scientific record."

Based on interview and record review, the hospital did not ensure that preventive actions were put into place after two medication errors were identified: 1) Medication was given to the wrong patient 2) Patient received a drug that was on their list of allergies. This had the potential to increase the risk of a poor health outcome for all patients receiving medication in in a universe of 174 patients..

Findings:1) On July 9, 2015, at 5:30 PM, the clinical record for Patient 49 was reviewed. The physician's orders indicated that the patient was started on "Atarax (a medication used to reduce itching from allergic reactions) 25mg (milligram) po (by mouth) Q6° (every 6 hours) prn (as needed) ------> itching 1st dose now" and was documented as written on February 17, 2015 at 10:40 (AM). Also written at the same time and date was "1% Hydrocortisone (a medication used to reduce redness and irritation of the skin) to rash QID (4 times daily)".

A review of the 24 Hour Notes (notes written by nurses to document a patient's current health status) from February 17, 2015 with a time of "1050" indicates that a nurse documented, "Patient has rash to arms, legs, and bottoms.....Possible antibiotic reaction." Notes at "1130" indicate, "Atarax 25mg po given for itching".

During an interview with the Director of Quality Management (DOQ) and the Quality Coordinator (QC) on July 9, 2015, at 5:30 PM, they confirmed that Patient 49 had received a medication ordered for another patient. The medication was cefazolin (an antibiotic) 1,000mg/50mL (milliliter) IV (intravenous - in the vein). In the interview it was revealed that Patient 49's daughter reported on February 18, 2015, that she found an IV medication hanging on her mother's IV pole and the name was not her mother's. The hospital investigated the incident and concluded that the patient had received the antibiotic and developed an allergic reaction to it.
2. During a review of the medical record conducted on July 6, 2015 at approximately 2:38 PM, revealed that Patient 13 was admitted to the hospital on July 4, 2015 with admitting diagnosis of right lower lobe pneumonia (Lung inflammation caused by bacterial or viral infection), 5150 (involuntary psychiatric hold) suicidal attempt she swallowed excessive pills of Seroquel (a medication used to treat mental health problems). Systemic inflammatory response syndrome early sepsis (an inflammatory state affecting the whole body frequently a response of the immune system to infection), bipolar disorder (a mental illness that brings severe high and low moods), hypertension of benign variety (a form of blood pressure that tends to develop slowly and may not cause any noticeable symptoms for a number of years), history of marijuana, alcohol and tobacco dependence; obsessive compulsive disorder (a mental disorder where people feel the need to check things repeatedly).

During a review of the clinical record for Patient 13, history and physical report dated July 4, 2015 indicated the patient is allergic to penicillin and causes Patient 13 to have hives. A review of the medication administration record dated July 5, 2015 at 1:36 AM indicated no known allergies and included Rocephin (an antibiotic used to prevent or treat certain infections caused by bacteria) 1 gram IV (the infusion of liquid substances directly into a vein).

During an interview with the Registered Nurse Unit manager (RNUM3), on July 6, 2015 at 11:05AM, she confirmed that the medication administration record indicated Patient 13 has no known allergies.

During an interview with the Director of Pharmacy (DOP) on July 7, 2015 at 11:15 AM, she confirmed Patient 13 is allergic to Penicillin and that the medication administration record indicated no known allergies. The DOP stated, she confirmed Rocephin is part of penicillin.

The facility policy and procedure titled " Allergies-Identifying and Documentation OF" dated June of 2013, indicated "The RN should review allergy information obtained by others with the patient. Fax the allergy and medication history section to the Pharmacy as soon as possible. Pharmacy assigns a level of severity to allergic response to prevent dispensing inappropriate medications. Drug allergies should be included each time a new MAR is generated. If the physician orders conflict with documented allergies, the Pharmacy/RN should notify the physician and request an alternative treatment."

Based on interview and record review, the hospital governing body did not ensure that the pharmacy department was involved in the hospital wide quality assessment and performance improvement program. This practice increased the risk of medication errors in all the patients admitted to the hospital in a universe of 174 patients.

Findings:
1.The medication storage area on 4 Tower North, a telemetry unit, was inspected at 9:25 AM on July 8, 2015 with the Director of Pharmacy (DOP) and Pharmacy Technician Supervisor (Tech 1). Five (5) units of KCl 20 mEq in 100 mL solution was stocked in the ADC location designated for KCl 10 mEq in 100 mL solution.

Tech 1 stated KCl was a "high-alert" medication, would require a "double check," and was checked by the pharmacist to ensure accuracy before leaving the pharmacy. The pharmacy technician then would select the medication to be restocked on the ADC screen. The light on the ADC's bin would light up to guide the technician to the correct bin to restock the medication.

According to the facility's policy titled, "Nursing Unit Inspections," effective date 4/79, Policy section, "Each nursing care unit ... where medications are dispensed, administered, or stored, should be inspected at least monthly by the pharmacist." In the Procedures section, "... the Pharmacist will verify that: ...(d) Proper stock medications are available ... Automated Dispensing Machines (ADC) are spot-checked for accuracy and expiration."

According to the ADC's transaction record provided by the facility, five (5) units of KCl 10 mEq in 100 mL were stocked in the ADC on April 8, 2015 by Pharmacy Technician (Tech 3). On June 3, 2015, Pharmacist 1 (RPh 1) inspected the storage for KCl 10 mEq in 100 mL in the ADC, but did not discover the inaccuracy.

2. During a inspection of the PACU Omnicell ADC on July 9, 2015, at 8 AM, Registered Nurse 6 (RN 6) was asked to locate and retrieve a potassium chloride (KCL) 20mEq in 100mL injection from the ADC. RN 6 utilized the ADC controls to request the KCL 20mEq and a tray near the bottom of the ADC opened. In the tray were 10 pockets or areas where individual medications could be stored. KCL 20mEq was located in the 3rd pocket from the left in the top row. Two pockets to the left in the same row was KCL 10mEq in 100mL injection. It was noted that a green flashing light that is located on each pocket of the tray, to indicate to the nurse where the medication is located, was not flashing. When asked what happened to the light, RN 6 stated, "The light is missing." When asked if it was possible for a nurse to take KCL 10mEq injection instead of KCL 20mEq injection due to being close and no flashing light to indicate which medication to pull out, RN 6 stated, "Yeah, if they aren't checking."

On July 9, 2015 at 10:24 AM, Immediate Jeopardy #2 was called in the presence of Vice President Medical Affairs, Vice President Chief Operating Officer, Vice President Chief Nursing Officer, Vice President Support/Clinical Services, and the Director of Quality Management due to hospital's failure to ensure that the correct dosage of Potassium Chloride was stored in the Omnicell ADC.

On July 9, 2015 at 5:59 PM, Immediate Jeopardy #2 was abated in the presence of the Vice President Medical Affairs, Vice President Chief Operating Officer, Vice President Chief Nursing Officer, Vice President Support/Clinical Services, and the Director of Quality Management after an acceptable corrective action plan was presented, validated, and approved, by the survey team.

Based on interview and record review, the hospital did not ensure that the medical staff provided an accurate, complete and scientific patient medical record for two of 57 sampled patients (Patient 1 and Patient 10). This practice increased the risk of substandard medical care for all patients in the hospital, in a universe of 174 patients. patients.

Findings:

During a review of the clinical record for Patient #1, the Consultation Note, dated July 5, 2015, indicated "I started seeing him on July 5, 2015, it looks like it is July 6, 2015 now, time just flies when you are having fun."

During a review of the clinical record for Patient 10, the Procedure Note, electronically signed on June 16, 2015, did not indicate the date after "Date of Procedure" and did not indicate the Preoperative Diagnosis (reason for procedure) or the Postoperative Diagnosis (results of the procedure), as they were both left blank. Review of the Discharge Summary (summary of hospital events), electronically signed on June 3, 2015, indicated "Date of Admission: May 29, 2015 but did not indicate the date after "Date of Discharge" (date patient left the hospital) as it was left blank.

During an interview with DMS, on July 9, 2015, at 7:40 AM, he reviewed the clinical record for Patient 1, including the Consultation Note, dated July 5, 2015. When he was asked about the quote "time just flies when you are having fun ", which appeared in the patient's Consultation note, which is part of the permanent patient clinical record, he answered, "I don't know if anyone is checking quality of the dictated notes."

The hospital Medical Staff Bylaws, dated December 2014, indicated "The attending Practitioner shall be held responsible for the preparation of a complete medical record of each patient ...No medical record shall be filed until it is complete ...the attending Practitioner is responsible for furnishing a complete, accurate and scientific record. "

Based on interview, and record review, the facility failed to:

1) Ensure that medications were administered only upon the orders of a practitioner for one of 57 sampled residents. As a result, the patient received a medication ordered for another resident and developed an allergic reaction to the medication.

2) Ensure one (1) medication, Ketoconazole (Nizoral, a medication used to treat fungal infection), was administered according to the order of the physician for one of 57 sampled patients. As a result, Patient 47's skin condition was untreated and had the potential to expose the patient to unnecessary harm.

Findings:

1) On July 9, 2015, at 5:30 PM, the clinical record for Patient 49 was reviewed. The physician's orders indicated that the patient was started on "Atarax (a medication used to reduce itching from allergic reactions) 25mg (milligram) po (by mouth) Q6° (every 6 hours) prn (as needed) ------> itching 1st dose now" and was documented as written on February 17, 2015 at 10:40 (AM). Also written at the same time and date was "1% Hydrocortisone (a medication used to reduce redness and irritation of the skin) to rash QID (4 times daily)".

A review of the 24 Hour Notes (notes written by nurses to document a patient's current health status) from February 17, 2015 with a time of 10:50 AM indicates that a nurse documented, "Patient has rash to arms, legs, and bottoms.....Possible antibiotic reaction." Notes at 11:30 AM indicate, "Atarax 25mg po given for itching".

During an interview with the Director of Quality Management (DOQ) and the Quality Coordinator (QC) on July 9, 2015, at 5:30 PM, they confirmed that Patient 49 had received a medication ordered for another patient. The medication was cefazolin (an antibiotic) 1,000mg/50mL (milliliter) IV (intravenous - in the vein). In the interview it was revealed that Patient 49's daughter reported on February 18, 2015, that she found an IV medication hanging on her mother's IV pole and the name was not her mother's. The hospital investigated the incident and concluded that the patient had received the antibiotic and developed an allergic reaction to it.

2) According to the facility's policy titled "Medication Administration: Administration of Medications", effective date 4/83, supersedes 5/11, "All drugs ... shall be... administered according to the physician orders..."and "...The nurse administering the medication ... shall document ... on the MAR following administration."

Patient 47's clinical record was reviewed with RN 1 and RN 2 at 10:50 AM on July 7, 2015.

On July 4, 2015, the physician ordered: Nizoral 2% [two percent] cream to "butt folds" twice daily.

RN 1 confirmed the medication administration was not documented on the Medication Administration Record (MAR).

During an interview at 11:00 AM on July 7, 2015, RN 3 confirmed the medication was not administered to the skin area as ordered by the physician.

Based on interview and record review the facility failed to assess, provide basic safe practice, and monitor an intravenous (IV) infusion for infiltration (an occurrence of IV fluid seeping out of the vein into the surrounding body tissue) of a medication administration that has the potential to cause fluid filled lesions (blisters), for one of 57 sampled patients (Patient 25).

This failure had the potential to cause further serious injury with possible necrosis (a form of body cell injury, or body cell death caused by infection, toxin or trauma) of the affected left arm, resulting in possible exposure to a hospital acquired infection, unnecessary medical treatment, and an extended hospital stay.

Findings:

During a review of the clinical record for Patient 25, the Medical/Surgical (Med/Surg) Unit Flow Sheet dated July 3, 2015 at 1:50 PM, indicated "...D/C CVC (a central venous catheter usually placed in a larger vein) after peripheral IV placed!" A continued review of the Med/Surg Flow Sheet, IV section - IV site: indicated the "left ? (not legible), SL (saline lock), Site Appearance: (no documentation), Site Check Times: 3:20 and 5:30 indicated (per flow sheet requirements, the site check times should be documented every 2 hours), Comments/Interventions - line is patent."

A review of the clinical record titled "Medication Administration Record (MAR)" dated Friday, July 3, 2015 indicated "Sodium Phosphate, 10 mmol (a unit of measure) - intravascular piggy back (IVPB) over three hours, times 1 dose" was given at 3:40 PM. Continued review of the MAR indicated "Vancomycin/D5W 1000mg in 200 milliliters (ml-a unit of measure) infuse over 90 minutes every 12 hours" was given at 8 PM.

A review of the Med/Surg Unit Flow Sheet dated July 3, 2015, (no time documented), documentation in the IV section revealed the following: IV site L (left) wrist, peripheral (type of access i.e. saline lock, not indicated), Solution /Time Bag Changed - Solution: D5LR, Rate ML/HR: 100, Site Appearance: Benign, Site Check Times: every 2 hours (every 2 hours check time not documented). Additional review of the flow sheet, Cardiovascular: Edema: "general edema" documented however, The "Pitting Edema (swelling of either the arms or legs/feet) Grading Scale" was without documentation that an assessment had completed.

Continuing review of the Med/Surg Unit Flow Sheet dated July 3, 2015 at 5:20 AM, indicated the "L (left) IV site swollen and has multiple blisters - IV discontinue (taken out) - blisters covered with Tegaderm (a clear adhesive bandage.)"

A review of the Med/Surg Flow Sheet clinical record dated July 4, 2015 at 7:00 AM, indicated "Patient has blisters developing to left arm, covered with Tegaderm (transparent dressing commonly used for skin cuts or blister) to protect from infection. Plan for patient is to continue with IV antibiotics." An additional entry into the Flow Sheet at 3 PM indicated "Change dressing to left arm, cover blister with Hydrogel Impregnated with silver."

Continued review of the Med/Surg Flow Sheet clinical record dated, July 4, 2015, the Cardiovascular section indicated "Edema: general edema, forearm edema; the Pitting Edema Grading Scale "was without documentation of assessment completed, Radial Pulse: Left "Did not assess" was documented; Skin Color: left arm "ecchymosis" (Non-raised skin discoloration caused by the escape of blood into the tissues from ruptured blood vessels).

Further review of the July 4, 2015 clinical record timeline, indicated at 9 PM "Scheduled meds administered, Vanco running per order" and at 2:00 AM "Flagyl running per order, new bag of D5LR hung." An additional entry in the Med/Surg Flow Sheet at 12:45 PM, indicated "MD ordered 'Silvadeen' treatment." Documentation indicating when the doctor was notified of the blisters could not be located within the clinical record.

A review of the Hospitalist Medicine Progress Note, dated July, 9, 2015 at 11:15 AM indicated the following:

Impression/Diagnosis - Left upper extremity - cellulitis
Plan - PO, IV Vanco
fluid blister - from ?

During an interview with the Director of the Medical/Surgical (DOMS) Unit, on July 9, 2015 at 2:45 PM, when asked how the blisters occurred on Patient 25's left arm she stated, "I do not know how the blisters occurred. I am not familiar with this patient and I would have to review the nurse's notes for the documentation." Additionally, the DOMS stated "the nurse who was caring for the patient is a night shift nurse. I cannot call her until after 3:00 PM."

During a concurrent interview with the DOMS, when asked if a wound nurse has seen the patient, she replied "We do not have a wound nurse. We have Wound Champions who help with wound management." When asked who oversee's the Wound Champions to ensure accurate assessment and treatment is appropriate, the DOMS stated, "RN Unit Manager 2 helps with assessing and evaluating wounds."

The facility policy and procedure titled "Intravascular Access Devices: Guidelines For The Prevention of Intravascular Catheter-Related Infections" dated 07/13, indicated "Introduction...provide necessary vascular access... their use puts patients at risk for local and systemic infectious complications including local site infection...General Care and Maintenance for All Intravascular Catheters in Adult...section 1.2 - Surveillance for catheter-related infection... Monitor the catheter sites visually or by palpation through the intact dressing on a regular basis... Selection of peripheral catheter insertion site... In adults, use an upper extremity site...Remove peripheral venous catheters if the patient develops signs of phlebitis (i.e., warmth, tenderness, erythema, infection, or a malfunctioning catheter.)"

Based on interview, and record review, the facility failed to follow its policy and procedures for patient's self-administration of medication, for one of 57 sampled patients. Patient 47 applied the Ketoconazole (Nizoral) cream by himself when there was no physician order to allow this practice. This finding had the potential to affect the health and safety of those patients self administering medications without a physician order.

Findings:

According to the facility's policy titled, "Medications left at the Patient's Bedside," effective date 4/79, it stipulated:

"1. Prescriber's orders in the patient's medical record are required for medications to be left at the patient's bedside."

"2. Appropriate education on drug use if provided to the patient...."

During a concurrent interview and record review at 10:50 AM on July 7, 2015, RN 1 and RN 2 concurred the physician ordered Ketoconazole cream for Patient 47.

During an interview at 11 AM on July 7, 2015, RN 3 stated the Ketoconazole cream had been left at bedside for Patient 47 to apply by himself. RN 3 stated Patient 47 was not provided with the appropriate education for self-administration the medication.

During an interview at 11:14 AM on July 7, 2015, RN 13 confirmed there was not a physician order for Patient 47 to self-administer the medication in the medical record.

Based on observation, interview, and record review, the facility failed to verify one of 57 sampled patients (Patient 13) medication allergies.This failure had the potential for Patient 13 to have an adverse reaction to Penicillin (Antibiotic that kills bacteria or prevent their growth) if administered.

Findings:

During a review of the medical record conducted on July 6, 2015 at approximately 2:38 PM, it revealed that Patient 13 was admitted to the hospital on July 4, 2015 with admitting diagnosis of right lower lobe pneumonia (Lung inflammation caused by bacterial or viral infection), 5150 (involuntary psychiatric hold) suicidal attempt she swallowed excessive pills of Seroquel (a medication used to treat mental health problems). Systemic inflammatory response syndrome early sepsis (an inflammatory state affecting the whole body frequently a response of the immune system to infection), bipolar disorder (a mental illness that brings severe high and low moods), hypertension of benign variety (a form of blood pressure that tends to develop slowly and may not cause any noticeable symptoms for a number of years), history of marijuana, alcohol and tobacco dependence; obsessive compulsive disorder (a mental disorder where people feel the need to check things repeatedly).

During a review of the clinical record for Patient 13, history and physical report dated July 4, 2015 indicated the patient is allergic to penicillin and causes Patient 13 to have hives. A review of the medication administration record dated July 5, 2015 at 1:36 AM indicated no known allergies and included Rocephin (an antibiotic used to prevent or treat certain infections caused by bacteria) 1 gram IV (the infusion of liquid substances directly into a vein).

During an interview with the Registered Nurse (RN 13) on July 6, 2015 at 11:05AM, she confirmed that the medication administration record indicated Patient 13 has no known allergies.


During an interview with the Director of Pharmacy (DOP) on July 7, 2015 at 11:15 AM, she confirmed Patient 13 is allergic to Penicillin and that the medication administration record indicated no known allergies. The DOP stated, she confirmed Rocephin is part of penicillin.


The facility policy and procedure titled "Allergies-Identifying and Documentation OF" dated June of 2013, indicated "The RN should review allergy information obtained by others with the patient. Fax the allergy and medication history section to the Pharmacy as soon as possible. Pharmacy assigns a level of severity to allergic response to prevent dispensing inappropriate medications. Drug allergies should be included each time a new MAR is generated. If the physician orders conflict with documented allergies, the Pharmacy/RN should notify the physician and request an alternative treatment."

Based on interview and record review, the facility failed to follow and implement the medical staff bylaws to ensure multiple physician telephone orders were signed/authenticated within 48 hours by the ordering physician, for two of 57 sampled patients (Patient 5 and Patient 29). This failure of not signing/authenticating physician telephone orders had the potential to adversely affect the overall health and safety of the patients in a universe of 174 patients.

Findings:

During an interview and concurrent review of the clinical record on July 08, 2015 at 3:28 PM, the RN Unit Director 2 stated, "There were multiple physician telephone orders that were not signed by physician," The RN Unit Director 2, further stated, "It should have been signed within 48 hours of giving order."

The following physician telephone orders were not signed:

1. For Patient 5
a. On July 2, 2015 at 5:00 AM, "1 Amp (Ampule-small breakable glass containing medication) Atropine (injections used in the treatment of slow heart rate) x1 (one time only) for HR (heart rate) <50 (less than 50 per minute). 6 days after the physician telephone order was dictated.

b. On July 2, 2015 at 6:10 PM , "Increase NS (Normal Saline) to 72cc (cubic centimeter/form of measuring weight) per hour total." 6 days after the physician telephone order was dictated.

c. On July 4, 2015 at 3:13 AM, "Recheck CBC (Complete blood count) at 7:00 AM."
4 days after the physician telephone order was dictated.

d. On July 4, 2015 at 8:30 AM, "Hold subcutaneous (under the skin) Heparin (medication used as a blood thinner). Repeat H&H at 1600 (military time = 4:00 PM) 4 days after the physician telephone order was dictated.

e. On July 1, 2015 at 10:00 AM, "Midazolam (medication use for sedating seizure patient) (100mg/100ml) 5 mg/hr (milligram per hour). 7 days after the physician telephone order was dictated.

2. For Patient 29
a. On June 29, 2015 at 10:00 AM, "Resume diet - cardiac, no surgery today." 9 days after the physician telephone order was dictated.

b. On June 30, 2015 at 12:32 AM "Tylenol 650mg PO (by mouth) q4ø (every 4 hours) PRN (as needed) for pain (level 1-3) to (level 4-6) 1st. then if no relief, give Morphine 2mg IV (intravenously-through the vein) q4ø PRN for pain (level 4-6) or Morphine 4mg IV q4ø PRN for pain (level 7-10)." Eight days after the physician telephone order was dictated.During a review of the " Medical Staff Bylaws " (name of hospital), dated August 2014, page 96, "Order 4: Orders dictated over the telephone shall be signed by the person to whom dicated with the name of the physician per his/her own name. Within 48 hours, the ordering hysician shall sign all medication orders."

Based on interview and record review the facility failed to ensure a history and physical assessment was completed, documented, and placed into the patient's clinical record, within the required 24 hours after admission to the facility, for one of 56 sampled patients (Patient #3). This failure placed the patient at risk for not receiving the appropriate treatment and plan of care, based on the patient's current and historical health condition(s).

Findings:

A review of the clinical record for Patient 3, the document titled "History and Physical (H&P - a document completed by the doctor that includes a history of the patient's present illness, and a review of the patient's past medical history) could not be located in the patient's clinical record.

During an interview with the Critical Care Unit Director (RN Unit Director 2), on July 7, 2015 at 12:10 PM, she reviewed the clinical record and was unable to find documentation of the H&P within the chart.

During a concurrent interview with RN Unit Director 2, when asked if an H&P should be in the patient's clinical record she stated "Of course, she should have an H&P in the chart." Additionally, when asked what the facility policy requirements are for obtaining, and placing a copy of the H&P into the clinical record, she stated "It should be in the chart within 24 hours of admission to the hospital. It's just not there."

The facility document titled (name of hospital) - Medical Staff Bylaws" dated December 2014, indicated "Each member of the Medical Staff shall perform...or arrange for the performance of, a history and physical on every patient he/she admits. A medical history shall be taken and a physical examination shall be performed within twenty four (24) hours of admission..."

Based on review of clinical record, hospital policy and procedures and staff interviews, the hospital failed to ensure that its staff accurately documented the care provided to one of 57 sampled patient (Patient 25) Two nurses (RN 4 and RN16) documented in the Patient 25's clinical record that a medication for the treatment for a pressure ulcer and the other was an intravenous medication was administered to Patient 25, but in reality it was not administered. This finding resulted in inaccurate and incomplete entry of care not provided to Patient 25s' Clinical Medical Record.

Finding:
Patient 25 was admitted to the facility on 06/30/15 with updated diagnoses including C.diff .(Clostridium difficile colitis is an inflammation of the large intestine resulting from a bacteria causing severe diarrhea) and Septic Shock, Pressure Ulcer Stage II Pressure ulcer is an injury to the skin and underlying tissue resulting from prolonged pressure on the skin. A stage II pressure ulcer according to the National Pressure Ulcer Advisory Panel (NPUAP) is partial thickness loss of dermis (second layer of the three major layers of skin) presenting as a shallow open ulcer with a red pink wound bed, without slough (dead tissue).
Review of 24 hour notes indicated Patient 25 had " blanchable redness to coccyx (Stage I) and Stage 2 (II) " the notes did not state the location of the Stage II. The Initial/Weekly Wound Photo Documentation photographs document a Stage 2 pressure ulcer measuring 7cm (centimeter) by 1 cm. to the Sacrum/Coccyx, wound bed red and no drainage. There was no reference to two smaller areas of skin breakdown on either side of the main wound. Five hours after admission, there was documentation that new orders obtained due to "coccyx breakdown." This documentation shows that the pressure ulcer to the coccyx progressed from a Stage I to Stage II during the first hours in the hospital. Nursing notes on 7/1/15 at 1200 document " wound assessed, .... Will continue to monitor. I t was not evident what the wound assessment was as there was no description on the condition, size and stage of the wound. Documentation on the 24 Notes on 7/2/15 at 3 AM described as "Skin tear to coccyx ..." Patient 25 was transferred to a medical unit on 07/03/15 three days after admission and, his pressure ulcer was assessed as a Stage III. NPUAP describes Stage III as " full thickness skin loss. Subcutaneous fat may be visible but bone, tendon and muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling " .Review of the Initial/Weekly Wound Photo Documentation showed a photograph of the wound was taken on 7/3/15. The only information on the form was under " Drainage amount/Description", "scant" was checked off. There was no other information document such as wound size (length, width, depth) appearance, stage, etc. Two nurses signed off on this form. The section on Physician verification indicating that the presence, status, and location of wounds as documented and described by nursing staff was verified was not signed by the physician. The wound based on the photographs had worsened from the one taken on admission. The main wound appeared deeper.

According to hospital policy titled "Pressure Ulcer Prevention Care, and Treatment " dated 04/11, under the heading " Wound Measurement " staff is guided to measure length, width and depth. It states " Location should be noted referencing appropriate anatomical landmarks " . There were two smaller area of ulcer in addition to the main (larger) wound, this information was not documented in the record.
In an interview with RN 13 on 7/8/15 at 11:50 AM, RN 13 acknowledged that it should have been documented. In a subsequent interview with RN 13 on 07/08/15 at 2:00 pm on lack of documentation of the wound in nursing notes, she indicated that wound documentation would not have been available from 07/04/15 through 07/07/15 because the dressing was changed every three days. Review of the Med/Surg nursing flow sheet indicated that a dressing change was done to the LUE (left upper extremity, site of the blister related to IV). There was no documentation the dressing change occurred to the coccyx.
In an interview with the Director of Education (DE) on 07/08/15 at 8:45 AM, she stated all nursing staff had been educated on assessment and treatment of wounds including pressure ulcer. Review of education records showed all nurses, (at least five) that provided care during Patient 25's stay had completed the training.
On 07/01/15, Patient 25's Laboratory results showed low calcium level and on 7/3/15, an order for intravenous sodium phosphate was ordered at 1200 to be given over 3 hours. On 07/03/15, another physician ordered "Santyl (medication used for bed sore) for wound " Review of Medication Administration Record (MAR) dated "July 03, 2015 showed documentation that the intravenous sodium phosphate was given at 1540 by RN 17. The same MAR showed Santyl was given at 1200 by RN4. The administration of the order was questioned because the order was not written until 1400 hours, 2 hours later. The documentation was handwritten " Santyl to coccyx wound with dressing change daily." The initial order did not include frequency of dressing change.
On 7/4/15 nursing documented multiple blisters in IV (intravenous) site. On 07/04/15, the physician completed a "Wound Physician Order" . There were orders in the Stage II areas for ruptured/deroofed blister, hydrogel + transparent Film dressing was checked off. In the Stage III and IV section under moderate to heavy drainage (suspected infection) "Apply Silver Impregnated dressing if not allergic to silver" was checked off.
Review of Medication Administration Record (MAR) dated "July 04, 2015" showed documentation the silver impregnated dressing, hydrogel and transparent dressing with pad were administered. It was not clear what dressing was done since there were two areas to be treated. In another page of the MAR also dated " July 04, 2015," there was a hand written documentation of dressing change to the wound with Santyl. On 07/05/15, nursing notes by RN 16 indicated a different kind of dressing was applied to the coccyx. Also documented as administered was a hand written order " Dressing change to wound Daily with Santyl " . The documentation did not reflect current physician order. Nursing staff documented that Santyl was used with dressing change for three days.
At 5:00 PM on 7/8/15 RN 12 was interviewed on whether there was Santyl in the medication cart for use for Patient 25 or any other patient on the floor. She denied the presence of the medication. At 5:10 PM RN Manager (RN 13) stated that either the pharmacist or the RN should have clarified the order. Review of Hospital policy and procedure (P/P) titled "Legibility of Medical Record Documentation" dated 05/01 indicated, under the heading "Pharmacy Interventions," "...pharmacists initiate a phone call/contact with the prescribing practitioner to clarify a medication order". In the same P/P under the heading "Illegible Medication and Procedures Orders", it states "Medication orders that are illegible, unclear or incompletely written will not be carried out until clarified in writing or rewritten. The procedure to be carried out is "individual wrote the original order will be contacted. If he/she is not available, then the covering practitioner will be contacted " .
In an interview with Pharmacy Tech 1(Tech 1) on 7/8/15 at 4:30 PM, he stated that the hospital pharmacy did not stock (keep on hand) Santyl. In an interview with Pharmacist (P 1) on 7/8/15 at 4:46 PM, she indicated that the Santyl order was never filled because it was an incomplete order. She stated she had sent a note to the nurse asking for order clarification. She stated she did not contact the physician. Pharmacist stated the nurse was responsible for the clarification.
In an interview with RN unit Director (RN Unit Director 2) and Director of Quality Management (DOQ) on 07/09/15 at 9:00 AM, RN Unit Director 2 stated that she had interviewed RN 16 but RN 16 did not want to be interviewed by the surveyors. RN Unit Director 2 stated RN 16 acknowledged the error and that she had not used Santyl on Patient 25. RN16 according to RN Unit Director 2, copied the information on previous MAR.
Also RN 4 was interview by the RN Unit Director 2 and DOQ. In the concurrent interview, RN 4 according to them, stated that she took the order for sodium phosphate and wrote it in the MAR including the time (1200) the order was written in another column below but she did not explain why she initialed it as if it was given.
In response to a question on how the hospital assures accuracy of MAR, the Chief Nursing Officer on 07/08/15 at 3:20 PM stated every nurse on the night shift was responsible for the accuracy of the MAR of the patients they provide care to.

The Hospital Policy and Procedure titled "Medication Administration: Administration of Medications & MARS Use" dated 06/13 was reviewed on 7/9/15. The P/P states "All newly printed MARs must be checked and verified against old MARs by the night shift RN to ensure completeness. Verifying RN will sign, initial and date the new MAR after checking. Ensure that all new orders and changes to existing orders are incorporated into the new MAR. Make any additions manually. Notify Pharmacy of any discrepancy either by sending a computer message via HBOC System ... or by completing a MAR discrepancy form and faxing ..... New orders after 2200 will not be printed on the new MAR and must be hand written in by nursing and will appear on the next day's MAR" . RN 16 failed to follow hospital policy on use of the MAR.

The hospital failed to ensure the Condition of Participation: CFR 482.25 Pharmaceutical Services was met by failing to:

1. Ensure medications were properly stored and secured, policies and procedures were implemented for controlled medication and compounded sterile medications. (Refer to A 0491)

2. Implement policy and procedures to minimize drug errors as it related to the use of unapproved abbreviation in an anticoagulant medication order. As a result, there was a potential for a ten-fold overdose of anticoagulant to be administered to patient, which can cause bleeding and death. (Refer to A 0500)

3. Ensure medications were appropriately labeled with the appropriate beyond-use-date (BUD) according to manufacturer's specifications and facility's policies. As a result, there was a potential for the medication to be administered after the BUD had passed. (Refer to A 0501)

4. Ensure medications were securely stored, therefore allowing unauthorized personels and visitors to have access to dangerous medications. These situations potentially could pose a hazard to patients and visitors. (Refer to A 0502)

5. Ensure mislabeled, outdated, and unusable medications were not available for patient use. (Refer to A 0505)

On July 9, 2015 at 10:24 AM, Immediate Jeopardy #2 was called in the presence of Vice President Medical Affairs, Vice President Chief Operating Officer, Vice President Chief Nursing Officer, Vice President Support/Clinical Services, and the Director of Quality Management due to hospital's failure to ensure that the correct dosage of Potassium Chloride was stored in the Omnicell ADC (An automated dispensing machine used to store and dispense medication.) (Refer to A 0491)

On July 9, 2015 at 5:59 PM, Immediate Jeopardy #2 was abated in the presence of the Vice President Medical Affairs, Vice President Chief Operating Officer, Vice President Chief Nursing Officer, Vice President Support/Clinical Services, and the Director of Quality Management after an acceptable corrective action plan was presented, validated, and approved, by the survey team.

The cumulative effect of this systemic problems resulted in the failure of the hospital to deliver care in a safe manner to be in compliance with the Condition of Participation: CFR 482.25 Pharmaceutical Services.

Based on observation, interview, and record review, the facility failed to ensure medications were stored appropriately as evidenced by:

1. Potential interchange of potassium chloride for IV (intravenous - in the vein) solution:

a. Potassium chloride (KCl, medication used to treat low potassium level) 20 mEq (milliequivalent) in 100 mL (milliliter) solution was stocked in a Omnicell ADC (automated dispensing cabinet used for dispensing medication in the patient care areas) location designated for KCl 10 mEq in 100 mL solution in the telemetry unit (an area of a hospital where the staff closely monitor patients, especially for changes in the rate and rhythm of the heart). This had the potential for the staff to administer twice the amount of KCl ordered to eight (8) patients in the telemetry unit, potentially causing the heart to stop.
b. Potassium chloride 10mEq in 100mL solution was stocked in a Omnicell ADC in the pre-anesthesia care unit (PACU - a unit where patients recover from procedures that utilized anesthesia) in the same tray as Potassium chloride 20mEq in 100mL solution and the ADC system to alert the nurse which medication to choose was not working. This had the potential for the patient to receive half the dose ordered by a physician for two (2) patients in the PACU, potentially leading to insufficient therapy in critical situations requiring potassium dosing.

2. Dextrose-containing solution (D5W) and dextrose-containing solution with electrolytes (D5LR) were stored in the storage bin designated for salt-containing solution (normal saline, NS). This had the potential for the incorrect medications to be administered to patients.

3. Medications not stored according to specifications:
a. Cefazolin (an antibiotic) 2 gram, azithromycin (an antibiotic) 200mg (milligram)/5mL (milliliter), penicillin VK (an antibiotic) 250mg/5mL, amoxicillin/clavulanate (an antibiotic) 250mg-62.5mg/5mL, cephalexin (an antibiotic) 250mg/5mL, and phenylephrine opthalmic (eye drops used to dilate the pupils) 2.5% were refrigerated. The manufacturer has recommended that the phenylephrine opthamic medication is to be stored at room temperature.
b. Famotidine (a stomach acid reducer) 20 mg injection, Vancomycin (an antibiotic) 500 mg oral solution were stored at room temperature. The manufacturer or pharmacy directions specified that the Famotidine is to be stored refrigerated.
c. Budesonide (Rhinocort, medication used to treat asthma) nebulization 0.25 mg in 2 mL was not labeled with the beyond-use-date (BUD) after opened as specified by the manufacturer.
d. Medications were exposed to light while the manufacturers specified to be protected from light.

4. Controlled drug schedule IV was not securely stored according to facility's policy.

5. Medications compounded for immediate use did not follow current standards of practice.

6. Temperature alert settings for the medications refrigerators were not consistent with facility's policy, and responsible staff was not notified when temperatures were out of the defined range.

These deficient findings had the potential to affect the health and safety of all patients in the hospital who were receiving these specific medications.


Findings:


1a. The medication storage area on 4 Tower North, a telemetry unit, was inspected at 9:25 AM on July 8, 2015 with the Director of Pharmacy (DOP) and Pharmacy Technician Supervisor (Tech 1). Five (5) units of KCl 20 mEq in 100 mL solution was stocked in the ADC location designated for KCl 10 mEq in 100 mL solution.

Tech 1 stated KCl was a "high-alert" medication, would require a "double check," and was checked by the pharmacist to ensure accuracy before leaving the pharmacy. The pharmacy technician then would select the medication to be restocked on the ADC screen. The light on the ADC's bin would light up to guide the technician to the correct bin to restock the medication.

According to the facility's policy titled, "Nursing Unit Inspections," effective date 4/79, Policy section, "Each nursing care unit ... where medications are dispensed, administered, or stored, should be inspected at least monthly by the pharmacist." In the Procedures section, "... the Pharmacist will verify that: ...(d) Proper stock medications are available ... Automated Dispensing Machines (ADC) are spot-checked for accuracy and expiration."

According to the ADC's transaction record provided by the facility, five (5) units of KCl 10 mEq in 100 mL were stocked in the ADC on April 8, 2015 by Pharmacy Technician (Tech 3). On June 3, 2015, Pharmacist 1 (RPh 1) inspected the storage for KCl 10 mEq in 100 mL in the ADC, but did not discover the inaccuracy.

1b. During a inspection of the PACU Omnicell ADC on July 9, 2015, at 8 AM, Registered Nurse 6 (RN 6) was asked to locate and retrieve a potassium chloride (KCL) 20mEq in 100mL injection from the ADC. RN 6 utilized the ADC controls to request the KCL 20mEq and a tray near the bottom of the ADC opened. In the tray were 10 pockets or areas where individual medications could be stored. KCL 20mEq was located in the 3rd pocket from the left in the top row. Two pockets to the left in the same row was KCL 10mEq in 100mL injection. It was noted that a green flashing light that is located on each pocket of the tray, to indicate to the nurse where the medication is located, was not flashing. When asked what happened to the light, RN 6 stated, "The light is missing." When asked if it was possible for a nurse to take KCL 10mEq injection instead of KCL 20mEq injection due to being close and no flashing light to indicate which medication to pull out, RN 6 stated, "Yeah, if they aren't checking."

On July 9, 2015 at 10:24 AM, Immediate Jeopardy #2 was called in the presence of Vice President Medical Affairs, Vice President Chief Operating Officer, Vice President Chief Nursing Officer, Vice President Support/Clinical Services, and the Director of Quality Management due to hospital's failure to ensure that the correct dosage of Potassium Chloride was stored in the Omnicell ADC.

On July 9, 2015 at 5:59 PM, Immediate Jeopardy #2 was abated in the presence of the Vice President Medical Affairs, Vice President Chief Operating Officer, Vice President Chief Nursing Officer, Vice President Support/Clinical Services, and the Director of Quality Management after an acceptable corrective action plan was presented, validated, and approved, by the survey team.

2. The medication storage area on 5 Tower North was inspected with RN 9 at 10:55 AM on July 8, 2015. Medication storage bin labeled as NS 100 mL and 50 mL was stocked with D5W 100 mL, 50 mL, and D5LR.

3a. The medication storage on 4 Tower West was inspected with Tech 1 and DOP at 10:04 AM on July 8, 2015. Cefazolin 2 gram (unactivated, medication power in a separate chamber, diluting solution in a separate chamber) was found in the refrigerator. According to the manufacturer's (B. Braun Medical) current prescribing information (revised 5/2012), the medication, when unactivated , was to be stored at 20°C to 25°C (68°F to 77°F), or room tempeature.

The medication storage on Neonatal Intensive Care Unit (NICU) was inspected with RN 10 and the DOP at 2:35 PM on July 8, 2015. Phenylephrine 2.5% eye drop was found in the refrigerator. According to the manufacturer's (Akorn) current prescribing information (revised 1/2015), the medication was to be stored at 20°C to 25°C (68°F to 77°F), or room temperature.

The medication storage area in the Emergency Department (ED) was inspected on July 8, 2015, at 2:00 PM. Azithromycin 200mg/5mL dry powder for reconstitution was found in the refrigerator. According to the manufacturer's (Teva) package insert (a document created by the manufacturer to provide detailed medication information), it states "Store dry powder at 20° to 25°C (68° to 77°F)".

The medication storage area in the Emergency Department (ED) was inspected on July 8, 2015, at 2:00 PM. Penicillin VK 250mg/5mL dry powder for reconstitution was found in the refrigerator. According to the manufacturer's (Teva) package insert, it states "Store dry powder at 20° to 25°C (68° to 77°F)".

The medication storage area in the Emergency Department (ED) was inspected on July 8, 2015, at 2:00 PM. Amoxicillin/clavulanate 250mg-62.5mg/5mL dry powder for reconstitution was found in the refrigerator. According to the manufacturer's (Morton Grove Pharmaceuticals) package insert, it states "Store dry powder at 20° to 25°C (68° to 77°F)".

The medication storage area in the Emergency Department (ED) was inspected on July 8, 2015, at 2:00 PM. Cephalexin 250mg/5mL dry powder for reconstitution was found in the refrigerator. According to the manufacturer's (Teva) package insert, it states "Store dry powder at 20° to 25°C (68° to 77°F)".

3b. A medication cart on 5 Tower East was inspected with RN 9 and the DOP at 11 AM on July 8, 2015. The medication cart was a locked cart, used by the nurse to store medications, at room temperature, for each patient assigned to him or her. Famotidine 20 mg injection was found in the medication cart. RN 11 administered Famotidine to Patient 42 at 11:09 AM. RN 11 stated Famotidine was already at room temperature in the ADC.

According to the manufacturer's (West-Ward Pharmaceutical) current prescribing information (revised 1/2012), Famotidine injection was to be stored refrigerated at 2°C to 8°C (36°F to 46°F).

Inspection of the ADC on 5 Tower East with RN 9 and the DON was conducted at 2:05 PM on July 8, 2015. Ten (10) vials of Famotidine injection were found at room tempearture in the ADC. Evidence that Famotidine injection could be stored at room tempeature was requested. The facility was unable to provide the requested evidence at the conclusion of the survey.

The medication cart with Patient 44's medication was inspected with RN 12 at 5:10 PM on July 8, 2015. Vancomycin (an antibiotic) oral solution 500 mg in 10 mL was dispensed by the facility's pharmacy with the label "refrigerate" was found in the medication cart. RN 12 stated she removed the medication from the refrigerator at 4:30 PM, to be administered at 6 PM (one and one-half hour in advance). RN 12 stated she would usually remove medications from the refrigerator one to one and one-half hour in advance. RN 12 also stated she removed the earlier dose from the refrigerator at 11 AM and administered at 12 PM (one hour in advance). When asked how she could ensure the potency and integrity of the Vancomycin at room temperature at the time of administration, she stated "I don't know."

3c. According to the manufacturer's (Teva) current prescribing information (revised 8/2014) for Budesonide nebulization, the medication was to be protected from light by storing it in the aluminum foil envelop, and once the evelop was opened, the shelf life of the unused units was two (2) weeks (BUD - beyond use dating) when protected from light in the alumninum foil envelop.

The inspection of the medication storage in the pharmacy was conducted with the DOP and Pharmacy Manager (PM) at 10:45 AM on July 6, 2015. Eight (8) units of Budesonide nebulization 0.25 mg in 2 mL were found open on the pharmacy shelf without the BUD.

The medication storage on NICU was inspected with RN 10 and the DOP at 2:35 PM on July 8, 2015. Two (2) units of Budesonide 0.25 mg in 2 mL were found outside, three (3) units inside the aluminum foil envelop, and without the BUD.


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3d. During a tour of the Pharmacy Department on July 6, 2015, at 2:20 PM, the following medications were observed to be stored on the pharmacy medication area storage shelves available for patient use:

-Forty (40) metoclopramide (a medication used to treat acid in the stomach) 10mg (milligram)/2mL (milliliter) single-dose vials for injection in the pharmacy medication storage area shelf exposed to light.
-Twelve (12) ondansetron (a medication used for nausea) 4mg/2mL single-dose vials for injection on the shelf exposed to light.
-Ten (10) phenylephrine (a medication used to constrict blood vessels in the body) 10mg/mL single-dose vials for injection on the shelf exposed to light.
-Five (5) verapamil (a medication used to reduce blood pressure) 5mg/2mL single-dose vials for injection on the shelf exposed to light.
-Two (2) sumatriptan (a medication used to treat severe headaches) 6mg/0.5mL single-dose vials for injection on the shelf exposed to light.

According to the manufacturer package insert (a document created by the manufacturer providing detailed information regarding the medication) for metoclopramide, manufactured by Teva Pharmaceuticals, under the section "How Supplied", it states, "Protect from light."

According to the manufacturer package insert for ondansetron, manufactured by Heritage Pharmaceuticals, under the section "How Supplied/Storage and Handling", it states, "Protect from light."

According to the manufacturer package insert for phenylephrine, manufactured by West-Ward Pharmaceuticals, under the section "How Supplied", it states, "Protect from light. Keep covered in carton until time of use."

According to the manufacturer package insert for verapamil, manufactured by Hospira, Inc., under the section "How Supplied", it states, "Protect from light by retaining in package until ready to use."

According to the manufacturer package insert for sumatriptan, manufactured by West-Ward Pharmaceuticals, under the section "How Supplied/Storage & Handling", it states, "Protect from light."

During a concurrent interview, the storage of the medications in the pharmacy with the Director of Pharmacy and Pharmacy Manager were discussed and they confirmed that the medications were not protected from light.

During an interview with the Director of Pharmacy and the Pharmacy Manager on July 7, 2015, at 2:15pm, a facility policy & procedure for storage of medications in the pharmacy storage area was requested. The Pharmacy Manager stated, "We don't have a policy for storage of medications in the pharmacy. The only thing we have are policies for the nursing units and Omnicells."

4. During a tour of the pharmacy department on July 6, 2015, at 2:49 PM, patient's own medications brought from home were noted to be stored on the pharmacy storage area shelves. A security package bag labeled with the name of Patient 56, with the inventory contents listed, "Zolpidem (a medication used to help a patient sleep) 10mg" was found in a box containing other patient own medications brought from home security bags. The bag was opened and a medication card with 15 tablets of zolpidem 10mg, labeled with a retail pharmacy name and Patient 56's information, was confirmed with the Pharmacy Manager.

A review of the Controlled Substances Act, a statute describing United States federal drug policy, and managed by the Drug Enforcement Agency (DEA) and the Food and Drug Administration (FDA), lists zolpidem as a Schedule IV (C-IV - controlled drug schedule level 4).

A review of facility policy & procedure, titled "Medications Brought in by the Patient", with an effective date of "4/30/1979", and numbered "M-500", under the section "3. Medications Stored in the Pharmacy" states, "Controlled Substances will be stored in a separate area in the secure vault." Under "Key Points", the policy states, "Controlled Substances will be stored in the Omnicell (an automated dispensing machine used for drug storage and dispensing) Secure Vault."

During a concurrent interview, the Pharmacy Manager acknowledged that the zolpidem was not stored in the designated separate area secure vault. She stated, "The person who did this did not follow directions."

5. A review of a facility policy & procedure titled "IV Admixing by Registered Nurses", with an effective date of "06/13", and numbered "PCS1300040", indicates under the section "Procedure", the following: "2. IV solutions not mixed under laminar flow (an area created, usually by a hood machine, where a constant flow of air is created to prevent microbial infiltration) expire 24 hours after the time they were mixed OR at the end of their stability."

During an interview with the Director of Pharmacy and the Pharmacy Manager, the policy & procedure was discussed and they were asked to provide the basis for determining 24 hours as the expiration date for IV solutions mixed by nursing personnel not under a laminar hood. They stated that the previous Director of Pharmacy would know that information but they could not respond at that time.

A review of the facility policy & procedure titled "Compounded Sterile Pharmaceutical Preparations", with an effective date of "01/02/2014", and numbered "I-800", indicates that the hospital refers to USP (United States Pharmacopeia) 797 (a document published by USP to describe pharmaceutical compounding - sterile preparation), a widely recognized article and considered a standard for determining pharmaceutical compound expiration dating. The following statements are taken from the policy under the section "Policy and General Information - Procedures":

-"B.1. Refer to the USP-NF (USP National Formulary) Chapter 797 on Sterile Compounding."

-"C. Develop written policies and procedures including staff training/testing for the selected risk level in accordance with guidelines from USP-NF, chapter 797."

A review of USP 797, under the section "Immediate Use CSPs (compounded sterile products)", describes a process where IV solutions not mixed under a laminar flow hoods are given a 1 hour expiration date.

During a interview with the Director of Education on July 8, 2015, at 4:35 PM, she stated that they used USP 797 to determine the 24 hour expiration date policy for IV solutions not mixed under laminar flow. However, she further stated that they are now aware that the 24 hour expiration dating does not apply to the situation they are describing. She stated that they are going to "change the policy to immediate use with an expiration date of 1 hour."

6. During a tour of the Pharmacy Department on July 6, 2015, at 11:25 AM, the medication storage refrigerators were inspected. The "Main 2" refrigerator indicated that it's temperature was 8.1°C (=46.58°F).

A review of the facility policy & procedure titled "Medication Refrigerators", with an effective date of "09/94", and numbered "M-400", states "Policy Statement: 3. If the temperature is out of the range of 36-46 degrees F (2.2 - 7.7 degrees C), the Engineering Department shall be notified immediately, and the refrigerator will be checked and adjusted."

The Pharmacy Manager and Director of Pharmacy were asked if the Engineering Department was aware that the refrigerator was out of range. They stated they did not know and would have the Facilities Manager respond.

In a interview with the Facilities Manager on July 7, 2015, at 2:35 PM, temperature tracking logs for the pharmacy refrigerators were reviewed. A total of 4 logs were provided and labeled as "Chemo", "Main Refrig", "Vaccine", and "Ref2". The "Chemo" refrigerator log indicated that the alarm for out of range was set for 33°F and 48°F. "Main Refrig" was set for 35°F and 46°. "Vaccine" was set for 33°F and 46°F. "Ref2" was set for 33°F and 46°F. When asked if there is a delay in notification of out of range temperature, he stated that there is no delay. When asked why the differences in alarm settings for the refrigerators, the Facilities Manager stated, "They have been that for a long time." He further stated that they are now aware of the discrepancy with the policy and procedure and were going to update the alarm settings to match the policy.

Based on observation, interview, and record review, the facility failed to implement it's policy and procedures to minize drug errors when an unapproved abbreviation was used to order Heparin (an anticoagulant medication) for one of 57 sampled patients (Patient 46). As a result, there was a potential for a ten-fold overdose of anticoagulant to be administered to patient, which can cause bleeding and death.

Findings:

During a medication administration observation on the 5th floor at 8:44 AM on July 7, 2015, RN 5 administered Heparin 5000 unit to Patient 46.

Patient 46's clinical record was reviewed at 11:03 AM on July 7, 2015 with RN 2.

On July 5, 2015, the physician ordered: "Restart Heparin 5000U SQ (subcutanenously) Q12hrs (every 12 hours)."

According to the facility's policy "U-100.1; Approved by P&T (Pharmacy and Therapeutics) Committee," last approved 2/15, "U or u" were listed as "unacceptable" abbreviations, and were on the "Do NOT Use" Abbreviation List 2015. The "Potential Problem" was listed as "Mistaken as cc, zero (0) or a 4 causing a ten-fold overdose, e.g. 4U seen as 40 or 4u seen as 44." The list specified to "write out "unit"." In addition, the policy stated, "An abbreviation on the ... "Do NOT use" list should not be used in any of its forms ... anywhere in the patient's medical record as it applies to all orders and all medication-related documentation.... Orders with unapproved abbreviations cannot be accepted by Pharmacy...."

During an interview at 11:03 AM on July 7, 2015, RN 2 stated "U" was not an acceptable abbreviation.

Based on observation, interview, and record review, the facility failed to ensure medications were appropriately labeled for six of 57 sampled patients (42, 51, 52, 53, 54, 55):

1. One (1) compounded medication, Zosyn (an antibiotic) was labeled with the appropriate beyond-use-date (BUD, a date after which a medication should not be used) according to the facility's policy and procedures for Patient 42.

2. Opened vials of medication were labeled with the appropriate BUD according to manufacturer's specifications and facility's policy for Patients 51, 52, 53, 54, 55.

As a result, there was a potential for the medication to be administered after the BUD had passed. in a universe of 174 patients.

Findings:

1. During an interview at 9:15 AM on July 6, 2015, with the Director of Pharmacy (DOP) and Pharmacy Manager (PM), the PM stated she was not sure what BUD would be assigned to intravenous medications (medications administered directly into the vein) compounded by the Pharmacy Department.

During an observation of medication administration on the Oncology Unit with RN 9, RN 11, and the DOP, the label for Zosyn 2.25 g indicated was "Made" (compounded) on 6/30/15, and would expire (BUD) on 7/30/15 (30 days BUD). RN 11 stated the medication was stored in the refrigerator.

According to the facility's policy titled, "Compounded Sterile Pharmaceutical Preparations , "effective 1/2/2014, for "Low Risk Level" compounding, the medication was to be "...stored and exposed to not more than 48 hours at controlled room temperature, for not more than 14 days at a refrigerated temperature...."


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2a. During a tour of the 6th Floor West medication room on July 7, 2015, at 2:55 PM, the medication refrigerator was inspected. A opened multi-dose vial of labetalol (a medication used to reduce blood pressure) 100mg (milligram)/20mL (milliliter), 20mL vial, was found in a bin labeled with the room number for Patient 51. The vial was not labeled with anything other than the manufacturer's original labeling. No patient information or a date opened/expiration date label were found on the vial. The 6th Floor Telemetry Unit Manager stated that their policy is to use the vial one time and discard, and that it should not have been in the refrigerator.

2b. During a tour of the 6th Floor North medication room on July 7, 2015, at 3:30 PM, the medication refrigerator was inspected. A opened bottle of Latanoprost eye drops (a medication used to reduce pressure in the eye) was found labeled with Patient 52's information. There was no labeling to indicate the date of expiration of the opened bottle. This was confirmed by the 6th Floor Telemetry Unit Manager.

2c. During a tour of the 6th Floor South medication room on July 7, 2015, at 3:45 PM, the medication refrigerator was inspected. A opened vial of Lantus insulin (a medication used to reduce blood sugar levels) was found labeled with Patient 53's information. There was no labeling to indicate the date of expiration of the opened vial. In addition, a vial of Humalog insulin (a medication used to reduce blood sugar levels) was found labeled with Patient 54's information. There was no labeling to indicate the date of expiration of the opened vial. Both were confirmed by the 6th Floor Telemetry Unit Manager as not having a expiration date documented on the bottle by hospital personnel.

2d. During a tour of the Critical Care Unit Side 5 medication room, on July 8, 2015, at 9:45 AM, the medication refrigerator was inspected. A opened bottle of Latanoprost eye drops was found labeled with Patient 55's information. There was no labeling to indicate the date of expiration of the opened bottle. This was confirmed by the Critical Care Unit Director.

A review of the manufacturer package insert (a document prepared and provided by the manufacturer with detailed medication information) for Latanoprost indicates under the section "Storage", it states, "Once a bottle is opened for use, it may be stored at room temperature up to 25°C (77°F) for 6 weeks."

A review of the manufacturer package insert for Lantus indicates under the section "Storage", it states, "Open (In-Use) Vial: Vials must be discarded 28 days after being opened."

A review of the manufacturer package insert for Humalog indicates under the section "Storage", it states in a table to determine how long the medication can still be used, "In-Use (Opened) Room Temperature.....28 days, refrigerated/room temperature."

A review of the facility policy & procedure titled "Multi-dose Vials, Safe Handling Practices, and Expiration Dates", with an effective date of "8/85", and numbered "M-950", it states, "2.a. All MDVs (multi-dose vials) are to be labeled with date of expiration (last date the product is to be used) which is 28 days after opened (vial cap removed)/puncture, unless otherwise specified by the manufacturer. This will include all Insulins and Tuberculin (a medication used to test for tuberculosis infection (an infection of the lungs)) in the Pharmacy."

Based on observation, and interview, the facility failed to ensure medications were securely stored as evidenced by:

1. Nystatin (an antifungal medication) power, was not kept secured for two (2) of fifty-six (56) sampled patients (35, 46).

2. Automated Dispensing Cabinet (ADC or ADM) was opened and unattended, allowing unauthorized personels and visitors to have access to dangerous medications.

These deficient findings had the potential for those medications to be taken inappropriately as stored and could pose a hazard to patients and visitors in a universe of 174 patients.

Findings:

1a. During a medication administration observation on the 5th floor at 8:44 AM on July 7, 2015 with RN 5, Nystatin powder was observed on Patient 46's bedside table.

During an interview at 11:25 AM on July 7, 2015, RN 9 stated the medication was already in Patient 46's room when she came into the room at 8:44 AM. RN 9 stated the medication should have been brought out of the room after the nurse finished with the medication administration.


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1b. During a medication pass (medication administration by nursing to patient's in their rooms) review on July 7, 2015, at 9:50 AM, for Patient 35, the Registered Nurse 7 (RN 7) told the patient that she could not find the patient's Nystatin powder (a medication used for fungal infections) and was going to look for it or contact the pharmacy. The patient responded by stating, "It's right there in that bin.", and pointed to a plastic hospital bin stored along the wall at the foot of her bed. RN 7 confirmed that the Nystatin powder was found in the bin and administered the medication.

In an interview on July 7, 2015, at 10:15 AM, the 6th Floor Telemetry Unit Manager was asked whether the Nystatin should be stored in the patient's room. She stated, "No, it should not.". When asked where the medication should have been stored, the 6th Floor Telemetry Unit Manager and the Pharmacy Manager stated that it should be stored in the Unit medication room in a bin labeled "Inbox Pharmacy".

A review of the facility's policy & procedure titled, "Medications left at the Patient's Bedside", with an effective date of "4/79", and numbered, "M-600", it states, "Policy Statement: 1. Prescriber's orders in the patient's medical record are required for medications to be left at the patient's bedside."

During a review of the patient's clinical record on July 7, 2015, at 10:20 AM, no prescriber orders were found indicating that Nystatin may be left at the patient's bedside. This was confirmed by the 6th Floor Telemetry Unit Manager.

2a. During a tour of the Emergency Department on July 8, 2015, at 2 PM, an Omnicell machine (an automated dispensing machine containing medications for removal by nurses for patient care) was found with flashing lights indicating that the cabinet doors for the machine were open and available. Multiple cabinet doors were able to be opened and accessed. Some opened cabinets included medications such as Sodium Chloride 0.9% (a medication used for hydrating a patient) 1000mL (milliliter) injection bags, Sodium Chloride 0.45% (a medication used for hydrating a patient) 1000mL injection bags, Lactated Ringers solution (a medication used for hydrating a patient) 1000mL injection bags, and Dextrose 5% in water (a medication used for hydrating a patient) 1000mL injection bags. The cabinet doors were able to be accessed by patients or visitors. No hospital personnel were attending the machine or in line of sight. The Emergency Department Director was asked why it was open and unsecured, she stated, "It must have been left open due to the arrest." A "code" (a situation in which medical personnel perform procedures and administer medication in order to prevent the death of a patient) was currently being performed in a patient area on the opposite side of the Emergency Department.

2b. During a tour of the Emergency Department on July 9, 2015, at 7:35AM, the Omnicell machine was found with flashing lights indicating that cabinet doors were open and available. One of the open cabinets contained thirteen Sodium Chloride 0.9% for irrigation, 500mL bottles. When the the Emergency Department Director was asked if it was supposed to be open, she stated, "No. They are stocking." She acknowledged that no hospital personnel were present in the area and that the doors were accessible to patients or visitors.

Based on observation, interview, and record review, the facility failed to ensure mislabeled, outdated, and unusable medications were not available for patient use.

1. One intravenous medication, D5 1/2 NS 20 mEq KCl in 1000 mL (electrolyte solution, containing potassium, administered directly into the vein) was observed without a required label for Patient 45.

2. Expired, and unusable medications were found in the Neonatal Intensive Care Unit (NICU), High Land Urgent Care, Pharmacy Department, Procedural Areas, Radiology Department, the 6th Floor East and Telemetry Units.

This failure had the potential to expose patients, requiring hydration and mineral replacement, anesthesia, anti-infectives, or radiologic imaging, to medications that may not have the same potency or integrity intended by the manufacturer due to medications being used past their expiration date. Outdated medications may not provide the desired effect which can lead to patient harm in a universe of 174 Patients.

Findings:

1. During a medication administration observation on the nursing unit with RN 14 at 9:30 AM on July 7, 2015, one D5 1/2 NS 20 mEq in 1000 mL bag was being administered to Patient 45 via an infusion pump (intravenously), without the required labeling.

At 11:40 AM on July 7, 2015, RN 1 confirmed there was no label on the bag being infused to Patient 45.

According to the facility's policy titled, "Labels, Pharmacy Products and Prescriptions," effective date 2/06, supersedes 12/08, section "Intravenous Medication Drug Labeling," stipulated:

"(1) The name and phone number of the Hospital
(2) Patient's Information including:
a. Full name
b. Room number or nursing unit
c. Account number
d. Order Number
e. Bag Number
(3) Drug order information including:
a. Hang Date and Time
b. Frequency
c. Rate of Infusion"

2a. During the inspection of the medication storage on NICU at 2:54 PM on July 8, 2015 with RN 10, two (2) expired medications were found for Patient 43. Metronidazole 5.25 mg in 1.05 mL expired on July 8, 2015 at 12:40 PM, according to the label. Vancomycin 7.5 mg in 1.5 mL expired on July 8, 2015 at 12:20 PM, according to the label.

2b. During the inspection of the medication storage at Highland Urgent Care with RN 15 at 11 AM on July 9, 2015, Promethazine 12.5 mg suppository was found in the medication refrigerator with the expiration date of April 2015. RN 15 stated the medication had expired and should not have been in the medication refrigerator.


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2c. During a tour of the Pharmacy Department on July 6, 2015, at 10:15 AM, the following medications were identified as available for patient use on the Pharmacy storage shelves along with other usable medications:

Eleven 500ml (milliliter) injectable bags containing Dextrose 50% in water (a medication used for hydrating a patient) with a manufacturer expiration date of July 1, 2015. During a concurrent interview, Pharmacy Technician 2 confirmed the expired date and removed the medication from the shelf.

Five ampules of Xylocaine-MPF 1% 10mL ampules (a medication used to blunt pain during medical procedures) with a manufacturer expiration date of June 2015. During a concurrent interview, Director of Pharmacy confirmed the expired date and removed the medication from the shelf.

During an interview with the Director of Pharmacy and the Pharmacy Manager on July 7, 2015, at 2:15pm, a facility policy & procedure for storage of medications in the pharmacy storage area was requested. The Pharmacy Manager stated, "We don't have a policy for storage of medications in the pharmacy. The only thing we have are policies for the nursing units and Omnicells."

2d. During a tour of the the 6th floor East Unit medication room on July 7, 2015 at 3:13 PM, the following medication was identified as unusable in the storage shelves along with other usable medications:

One 1000mL injectable bag, manufactured by B. Braun Medical Inc., containing Dextrose 5% in water with 0.2% Normal Saline (a medication used for hydrating a patient) without the manufacturer's protective outer plastic wrap.

During a concurrent interview, the 6th floor Telemetry Unit Manager confirmed the bag did not have it's protective overwrap and that there was no label on the bag indicating a date removed or expiration date. When asked if she knew when the bag was removed from it's outerwrap, she stated she did not know. When asked if she was aware of whether the bag was still usable after being removed from it's outerwrap, she stated she was not aware.

During a tour of the 6th floor North Unit medication room on July 7, 2015 at 3:30 PM, the following medication was identified as unusable in the storage shelves along with other usable medications:

One 500mL injectable bag, manufactured by B. Braun Medical Inc., containing Dextrose 5% in water (a medication used for hydrating a patient) with the manufacturer's protective outer plastic wrap broken. The bag was approximately 90% exposed to ambient air.

During a concurrent interview, the 6th floor Telemetry Unit Manager confirmed the outerwrap was broken and opened and that there was no label on the bag indicating a date opened or expiration date. When asked if she knew when the outerwrap was broken open, she stated she did not know.

A letter provided by the facility, from B. Braun Medical Inc., and addressed to a representative of Dignity Health Systems, dated February 28, 2014, states, "The EXCEL (the name of the bag system by the manufacturer) 250mL, 500mL, and 1000mL size containers without any additions can be stored at 25°C for one month without it's plastic overwrap (or until its expiration date, whichever is sooner)."

2e. During a tour of the Operating/Surgery/Anesthesia Unit medication storage room on July 8, 2015 at 11:10 AM, the following medications were identified as unusable in a warmer device (a machine used to keep medications at a warmer temperature than room temperature):

Eight 1000mL injectable bags of 0.9% Sodium Chloride (a medication used for hydrating a patient) without labeling indicating an expiration date.
-Twelve 1000mL injectable bags of Lactated Ringer's solution (a medication used for hydrating a patient and supplementing minerals) without labeling indicating an expiration date.

The warmer machine indicated the temperature as 40°C. During a concurrent interview, the Operating Room Department Director confirmed the bags were not labeled with an expiration date and stated, "They did not label these so we'll waste them." She had them removed from the warmer immediately.

According to facility policy & procedure, titled "Warming Cabinet; Management of Fluid and/or Blanket Storage", with an effective date of "1/15" and numbered "7420-7430-0513", under the section "Solution Expiration and Rotation", it states, "3.1.1 Mark IV Bag with indelible ink noting a 28 day expiration date from the date/time the IV bag is placed into the warming cabinet."

The manufacturer for the Sodium Chloride and Lactated Ringer's solution, B.Braun Medical Inc., was contacted on July 15, 2015, requesting information on the stability of their products in warmer devices. A subsequent official letter, dated July 15, 2015, was provided. It states, "The labeling for EXCEL products contains a statement that exposure of pharmaceutical products to heat should be minimized and that excessive heat should also be avoided." The letter also states, "Product that has been exposed to 40°C and not used within 4 weeks must be discarded and not returned to storage."

2f. During a tour of the Radiology Department medication room on July 8, 2015 at 3 PM, the following medications were identified as unusable in the storage shelves along with other usable medications:

One bottle of Gastrografin (a contrast dye medication used for radiologic imaging procedures) 120mL was found opened and approximately one-third full.

One bottle of Omnipaque (a contrast dye medication used for radiologic imaging procedures) 50mL was found opened and approximately three-quarters full.

The manufacturer labeling on every bottle of Gastrografin 120mL states, "Single dose bottle - Discard unused portion".

The manufacturer labeling on every bottle of Omnipaque 50mL states, "Once a sterile transfer needle or spike has been inserted into the container outlet site, withdrawal of container contents should be completed without delay. If fluid transfer cannot be completed without delay, discard the container no later than 8 hours after initial puncture."

During a concurrent interview with the Radiology Supervisor, he confirmed that the medication bottles were opened and stated, "It should have a date opened expiration date label on them." When asked if he knew when the bottles were opened, he stated that he did not know.


A review the a facility policy & procedure, titled "Nursing Unit Inspections", with an effective date of "4/79", and numbered "N-300", states, "1. Each nursing care unit or other area of the hospital where medications are dispensed, administered, or stored, should be inspected at least monthly by the pharmacist." If further states, "Procedure: 1. .....the Pharmacist shall verify that: a) Outdated, damaged, or otherwise unusable drugs have been identified and their distribution and administration prevented."

The hospital failed to ensure the Condition of Participation: CFR 482.28 Food and Dietetics Services were met by failing to:


1. Ensure that there was a system to identify unsanitary conditions (mold/spores) in one of the walk-in refrigerators in the hosptial kitchen which had the potential for contaminating all stored food items with mold/spores(circulated by air) served to all staff, visitors and patients serviced by the hospital. (Refer to A-0749).
On July 7, 2015 at 5:59 PM, Immediate Jeopardy #1 was called in the presence of the facility Chief Nursing Officer, Director of Quality Management, Director of Infection Control and Vice President of Support/Clinical Services due to the hospital's failure to ensure that there was a system to identify unsanitary conditions in one of the walk-in refrigerators in the kitchen. (Refer to A-0749).


On July 8, 2015 at 4:10 PM, the Immediate Jeopardy was abated in the presence of the facility's Vice President Medical Affairs, the Vice President Chief Operating Officer, the Vice President Chief Nursing Officer, the Vice President Support/Clinical Services, and the Director of Quality Management after an acceptable corrective action plan was presented, validated, and approved. (Refer A-749)

2. Ensure the dietetic service department was organized and staffed in a manner that ensured the needs of the patients were met. Deficient practices were observed in areas of staff training, kitchen sanitation, equipment maintenance, meal preparation and infection control practices. These failures had the potential to affect all admitted patients receiving meals from the kitchen, staff and visitors purchasing food from the cafeteria. (cross refer A622, A701, A724, A749).


3. Ensure that three dietary staff (KS1, FSW 4 and FSW 5) were able to properly test the chemical sanitizer in the sanitizing bucket. None of the employees immersed the test strip for the recommended (by the manufacturer) time of 10 seconds on the label. Immersion times varied form 5 seconds to 15 seconds. The Foodservice Director (FSD 1) stated in an interview on 07/08/15 at 8:50 am, that the former director (FSD 2) had provided training and laminated instructions as tools to help staff in testing the sanitizer correctly. Review of facility document title "Cleaning and Sanitizing," dated Feb. 2015, revealed two of the three dietary staff attended the training. (cross refer A622).

4. Ensure that the hospital's emergency preparedness plan was to be able to shelter in place for 4 days. This plan included the use of perishable food for the first 2 days and a dehydrated meal plan for the second phase. On 07/06/15, at 9:10 am, the hospital experienced a power outage; the refrigerators and freezer were unable to maintain temperatures because it was not connected to the emergency power source resulting in some foods being stored in the food danger zone (temperatures between 41 and 135 degrees Fahrenheit). In a true emergency, the failure of the refrigerator and freezer increased the potential for inadequate food for the patients and staff. (Cross refer A701).

In addition, the canned emergency food stored outside the kitchen in a metal container was stored without temperature monitoring. The temperature on 07/07/15 was above the recommended temperatures by the manufacturer. (Cross refer A701)

The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver food and dietetic services in a safe manner in compliance with the Condition of Participation for Food and Dietetic Services.

Based on observation, review of facility documents, laboratory analysis reports, and staff interviews, the hospital failed to ensure that the Dietary Supervisor developed a system on a daily basis to identify unsanitary conditions in one of the walk-in refrigerators in the kitchen when kitchen staff did not clean the refrigerator in a manner to prevent an overgrowth of mold/spores on several insulation pipes. The laboratory analysis conducted on 7/6/15 on parts of the insulation tubing revealed it was mold. In addition, the hospital failed to ensure that potentially hazardous foods were properly stored within recommended temperature ranges and monitored throughout the cooling process. These failures had the potential to affect all kitchen staff, other hospital staff, visitors and 174 patients that were admitted to the hospital through cross contamination of food items and surfaces of mold being circulated.

The failure to properly clean the refrigerator as a result of poor lighting, and lack of oversight, caused the growth of mold which resulted in an immediate threat to the health and safety of the hospital patients, staff and visitors. Immediate jeopardy was declared on 07/07/15 at 6:10pm. (A-749) An acceptable plan of action was provided by the hospital administrator on 07/07/15 at 7:00 pm. The actions to remove the immediate jeopardy situation included: quarantine the refrigerator, culture (test) the spores, use a professional cleaning company to clean the refrigerator, remove and replace the insulation piping and perform any needed repairs on the refrigerator unit.
The immediate jeopardy was abated (reduced in amount, degree or intensity) on 07/09/15 at 4:10 pm.

Finding:

During the inspection of the kitchen on 07/06/15 at approximately 9:45 am, there was a strong musty smell inside the walk -in refrigerator. The dimly lit refrigerator was inspected using a flash light. Underneath the condenser, there were several pipes covered with black insulation. Inspection revealed the presence of white and black colored substance on different areas of all of the pipe insulation. More of the black colored substance was observed on the walls and floor of the refrigerator. The presence of black colored substance was validated by laboratory analysis.

Food service director (FSD) was present during this observation. The FSD stated on 07/07/15 at 9:45 am the refrigerator was called the "Cook's" refrigerator. She stated in the concurrent interview the Executive Chef (EC) was responsible for ensuring the sanitation of the refrigerator. EC was interviewed at 9:50 am on 07/07/15. EC stated that the refrigerator was cleaned daily. He presented a copy of a document titled, "Master Cleaning Schedule," to show that the refrigerator was being cleaned. Review of the document at 10:00 am showed that the schedule did not include this refrigerator by name.

EC stated that the refrigerator was cleaned daily even if it did not list it by name on the schedule. The document showed the last time the areas listed on the cleaning schedule as being cleaned was on " 5/6 ", two months before, validated by the presence of an initial. EC stated that the refrigerator did not have any problems with temperatures. A review of the temperature log for the month did not reveal any temperature discrepancies. The temperature of the refrigerator on 07/07/15 at 10:00 am was 47.6 degrees Fahrenheit. The recommended temperature for a refrigerator is below 41 degrees Fahrenheit. Mold grows at all temperatures including 32 to 95 degrees Fahrenheit but seem to thrive at 77 to 86 degrees Fahrenheit (Wikipedia.com). The EC and FSD did not provide any information on why the refrigerator was not cleaned as scheduled or why no one noticed the overgrowth of mold.

During the meeting on the hospital's response to the immediate jeopardy situation and laboratory analysis report 07/08/15 at 4:00 pm, the infection control nurse stated the kind of mold found was a result of vegetables brought into the hospital and that it posed no risk to staff and patients. The analysis of the different kinds of mold did not support the assertion that it could not pose any risk to the staff, patients and visitors. Air sample analysis report showed presence of mold in two areas. She did not provide any information on how the infection control program failed to identify the problem.

The Review of laboratory analyses dated 07/08/15 done on the refrigerator tubing, metal and air samples showed the presence of several types of mold. Some of the examples include basidiospores 3+, mold, phoma/coelmycetes mold, torula mold 2+ and clasdosporium 3+, Chaetomium 4+. (The numbers following the name of each fungus/mold shows the density (abundance). The higher the number, the more abundant it is.)

Basidiospores are a form of fungus similar to mushrooms found in areas of high humidity (moisture). The known disease conditions caused by basidiospores are keratitis and pneumonia in immune compromised patients. It may also cause hay fever, asthma and mushroom sensitivity. Phoma/coelmycetes mold are known to cause hay fever and asthma.

Cladosporium is the most common indoor and outdoor mold. It is olive green to black in color. The airborne spores of Cladosporium species are significant allergens, and in large amounts they can severely affect asthmatics and people with respiratory diseases. Cladosporium produce volatile organic compounds (VOCs) associated with odors. The strong musty odor in the refrigerator is a result of this mold. Chaetomium is one of the molds which require chronic moisture conditions for it to grow. Its presence is therefore an indication of existing or previous serious moisture problem.

Two of the requirements for mold growth are moisture and temperature. According to the University of Central Florida, " most mold require a " considerable " amount of moisture for growth " . In an interview with the Facilities Management director and manger on 07/09/15 at 7:50 am, both indicated they do not have a record of problems with the refrigerator but believe the deterioration of the insulation due to " sweating " of the pipes was a contributory factor in the growth of mold in the cook ' s walk-in refrigerator.

During meal preparation observations on 07/07/15 starting at 9:38 am, a stainless steel pan containing slices of a light colored meat (pork) was observed in a congealed form with a light yellow layer (fat) in the cook ' s refrigerator. The temperature of the pork was 33 degrees Fahrenheit. The Supervisor was able to show that the pork cooled down to the recommended temperature within the recommended time (6 hours).

At 10:15 am, chicken breasts stacked on top of another (approximately 20) were in a medium sized pan in a thin layer of congealed liquid. A random temperature check of the chicken breast pieces showed temperatures ranging from 55 to 65.1 degrees Fahrenheit. Food service worker 1 stated in an interview that the chicken breasts had only be removed from the refrigerator a few minutes earlier. The cook (Cook A) who prepared the chicken was also interviewed; she stated that she had cooked the chicken about three hours earlier, at 7:00 am. Cook A denied using the cooling logs to monitor the cooling process. Review of the Cooling log showed that the pork was the last cooling time monitored. There were no other food items listed for 07/06/15 and 07/07/15.

Improperly cooling is a major factor in causing foodborne illness. Foods that have cooked and held at improper temperatures promote the growth of disease causing microorganisms that may have survived the cooking process. (CMS)

Based on observation, review of hospital documents, manufacturer's "instructions" and staff interviews, the hospital failed to ensure the dietetic service department was organized and staffed in a manner that ensured the needs of the patients were met. Deficient practices were observed in areas of staff training, kitchen sanitation, equipment maintenance, meal preparation and infection control practices. These failures had the potential to affect all meals for the kitchen, staff , visitors, and patients in a universe of 174 patients.

Findings:

According to the Food service director (FSD 1) the dietetic service is a contracted service. She stated in an interview on 07/06/15, at 11:30 AM , she assumed her position as the director only two weeks earlier. Review of the contract with the food management was done on 07/08/15. Details of the contract showed that the former foodservice director (FSD 2) had been in the position for about a year and half but not as a full-time employee as required by both federal and state requirements. In an interview with FSD 2 on 07/07/15, at 9:00 AM, she acknowledged that she had responsibilities for two hospitals as the directors of food service until two weeks before.

1. During an observation on 07/07/15, at 9:50 am, it was determined that the cook's refrigerator had not been properly cleaned. This failure resulted in the overgrowth of mold. Laboratory analyses confirmed the presence of mold. The different kinds of mold identified had the potential to cause hay fever and allergies to staff, visitors and patients with immune compromised conditions. Documented evidence showed the last documentation of cleaning completed to some of the kitchen areas was two months earlier on 5/6/15. This resulted in immediate jeopardy being declared.
2.During a review of the "Temperature Cooling Log" on 07/07/15, at 10:00 am the dietary staff did not consistently monitor temperatures for leftovers that were cooked, as required by the management company.
3. Food service worker (FSW) 5 was observed at 9:06 am preparing the salad bar. The temperatures of two of the items that were to be placed in the bar were higher than temperature recommended for cold food. The temperature of the egg salad was 46 degrees Fahrenheit and chopped eggs were 44.2 degrees Fahrenheit. The recommended temperature for cold food holding is 41 degrees Fahrenheit or below. FSW 5 stated her practice was to take temperatures of all the foods after they had been placed on the bar and if the temperature of the item was not in the recommended range she would remove the item.

During an Interview with FSW 1 at 9:45 AM, revealed that the egg salad was prepared about thirty minutes earlier using ingredients that had been stored in the refrigerator overnight. FSW 1 stated she did not check the temperature of the finished product before placing in the refrigerator.

Three of three dietary staff (KS1, FSW 4 and FSW 5) "were" not able to properly test the chemical sanitizer in the sanitizing bucket. None of the employees immersed the test strip for the recommended (by the manufacturer) time of 10 seconds on the label. Immersion times varied form 5 seconds to 15 seconds. The Foodservice Director (FSD 1) stated in an interview on 07/08/15 at 8:50 am, that the former director (FSD 2) had provided training and laminated instructions as tools to help staff in testing the sanitizer correctly. Review of facility document titled, "Cleaning and Sanitizing" dated Feb. 2015 revealed two of the three dietary staff attended the training.

4. The dish machine and steamer were not in good working condition.There was evidence that the dish machine had problems related to leaks that had been repaired by the maintenance at least thirteen times in the previous six months including three days earlier. These leaks resulted in a pool of water on the floor that was unsafe for kitchen employees and could potentially result in injuries related to falls.

5. The steamer was in poor working condition. There were stainless containers under the doors of each of the seamers to catch the water streaming from the steamers. One employee could not remember how far back it had been operated in that manner. This failure could result in burns to staff.

6. Review of the test trays conducted in April 2015 as part of the quality improvement revealed a significant temperature drop between trayline food temperatures and temperatures on patient floors. According to the Clinical Nutrition Manager (CNM) in an interview on 07/06/15 at 4:00 pm, this temperature drop was attributed to the failure of the plate warmers.

In an interview conducted at 11:00 am on 07/09/15 with Vice President of Support Services, (VPS) indicated that she was aware of the equipment problems in the kitchen and that these equipment are being addressed at the capital committee for replacement this fiscal year.

7. On 07/06/15 at 3:00 pm, there were items from lunch trayline on the steam table. There were approximately 15 pieces of hamburger patties, chicken and beef gravies, chopped and ground chicken, one piece of chicken, rice (two kinds).The hamburger was dried -out with a darker brown color at the edges, the ground and chopped chicken were dried out in parts exposed, the soups and gravy had a dried out film covering them, the rice was dried out crusty and stuck to the pan, the edges of the mashed potatoes next to the pan was dark brown and crusty, while the top was a light brown color and crusty on top. The one piece of chicken left in one of the pans was burnt. FSD 1 stated the temperatures were checked every hour and the left over food was served to patients on the late trays.The CNM stated patients received diet orders for late trays delivery are provided cold sandwichs after 2 pm.

8. A taste test of the items left on the steam table was conducted at 3:10 pm. The hamburger, chopped chicken were chewy and dried out. The FSD 1 stated that lunch trayline started at 11:00 am.

9. On 7/7/15 at 8:35 am, there were two pans containing a pasta dish stored in the warmer in the kitchen. FSD stated it was probably for the cafeteria which opened in two hours. At 11:35 am, the pasta dish that was in the warmer was being served for lunch, three hours later. If the pasta dish were left on the steam table till 2 pm, the dish would have been held for approximately seven hours. Although maybe safe in terms of temperature, the quality of the dish may be compromised.

10. The hospital's emergency preparedness plan was to be able to shelter in place for 4 days. This plan included the use of perishable food for the first 2 days and a dehydrated meal plan for the second phase. On July 9, 2015 the hospital experienced a power outage; the refrigerators and freezer were unable to maintain temperatures because it was not connected to the emergency power source resulting in some foods being stored in the food danger zone (temperatures between 41 and 135 degrees Fahrenheit). In the event of an extended emergency, the failure of the refrigerator and freezer has an increased potential to result in inadequate food stores for the patients and staff.)

In addition, the canned emergency food stored outside the kitchen in a metal container was stored without temperature monitoring. The temperature on 07/07/15 was above the recommended temperatures by the manufacturer.

The hospital failed to ensure the Condition of Participation: CFR 482.41 Physical Environment was met by failing to:
1. Ensure a safe environment for their patients from fire. This was evidenced by not providing a reliable emergency back-up power to continuously supply electricity to their critical Life Safety Systems and failed to provide continuous illumination to their path of egress to ensure a safe evacuation.(Refer to A 0710 and K106 and K046 of the Life Safety Code).2. To develop an effective comprehensive plan for the provision of food in an emergency when it failed to ensure that food supplies will be stored safely before and during an emergency. When the hospital experienced a power outage on 07/06/15, the freezer and refrigerators were not plugged into the emergency power resulting in refrigerator temperatures exceeding the recommended level of 41 degrees and below.(A 0701)

3. Ensure the food service equipment was maintained at an acceptable level of safety and quality. The temperature of the hot water in the hand washing sink in the kitchen was set at a level that would not result in injury to staff. There was no signage warning staff of this potential hazard.(A 0724) The cumulative effect of these systemic problems identified during the Life Safety Code (LSC) portion of the survey and during the Full Validation Survey resulted in the facility's inability to ensure the provision of a safe environment.

Based on observation, review of hospital documents, manufacturer's instructions and staff interviews, the hospital failed to develop an effective comprehensive plan for the provision of food in an emergency situation when it failed to ensure that food supplies will be stored safely before and during an emergency situaion such as a experienced a power outage. The freezer and refrigerators were not plugged into the emergency power resulting in refrigerator temperatures exceeding the recommended level of 41 degrees and below. In addition, the hospital failed to monitor storage temperatures of the emergency food stored outside the facility, and temperatures on 07/07/15 exceeded manufacturer's recommendations for the shelf life of the products. This had the potential to affect all admitted patients, staff and visitors that may need to be fed in an emergency situation in a universe of 174 Patients.

Findings:

On 07/06/15, the hospital experienced a power outage for approximately 2 hours 9:12 AM to 11:28 AM. During this period, dietary staff determined that the refrigerators and freezer were not connected to the emergency power source. As a result, temperatures of the refrigerator increased to over 41 degrees Fahrenheit. The recommended refrigerator temperature is 41 degrees and below.

At 11:35 AM, diet tuna salad that had been prepared earlier that morning was 68.5 degrees Fahrenheit. The temperature of Diet mayonnaise, which had egg, a potentially hazardous food (PHF) as one of its ingredients, was 45.3 degrees Fahrenheit. The temperature of egg salad was 69.3 degrees Fahrenheit.

At 2:47 PM, the 2 door refrigerator in which juices and jello were stored was 42 degrees Fahrenheit. The trayline air curtain refrigeration unit was 56 degrees Fahrenheit. The recommended temperature for cold storage and PHF foods is 41 degrees and below.

At 4:20 PM, several hours after power had been restored; the freezer and refrigerator temperatures were still below the recommended levels. The freezer was 10 degrees Fahrenheit, the recommended temperature is 0 degrees and below. The temperature of milk for patient trayline at 4:22 pm was 44.4 degrees Fahrenheit. The recommended temperature for refrigerated food is 41 degrees and below. Review of temperature logs for the walk in refrigerator at 6:00 pm on 07/06/15 showed it read 60 degrees Fahrenheit. Review of the maintenance log for work repairs on 07/09/15, showed the freezer, walk in refrigerators had been reported as "warm" . They were reset according to the document at 6:45 pm.

The foodservice director (FSD 1) stated in an interview on 07/07/15 at 10: 25 AM, the hospital had access to a refrigerated truck that could be utilized "within a few hours" in an emergency. The use of this truck was not part of the written plan. It also did not take into consideration that they truck may not be accessible if roads are affected during the emergency.

According to the Safety officer (DS) on 7/07/15 at 10:30 AM, the hospital plan based on the county emergency preparedness agency is to be able to shelter in place for 96 hours (4 days). Review of the hospital ' s emergency plan, titled " Disaster Preparedness Plan " updated 10/14 indicated in Phase One: Meals for 2 days of Perishable items. This implied and confirmed with the FSD 2 at 10:32 am that food on hand including the frozen and refrigerated foods would be utilized for the first two days and for phase Two; the hospital will use a dehydrated product for the remaining two days.

Review of the Phase One Disaster Menu Inventory document indicated that items such as juices, milk, puree entrees, cottage cheese, cheese, fresh and frozen vegetables, frozen dessert would be utilized the first two days of the disaster. Based on the failure of the freezer and refrigerators to maintain temperatures during the outage, the hospital ' s ability to safely and adequately provide food for the first two days of the emergency for its patients and staff was questionable. Potentially hazardous foods (PHF) or Time Temperature Control for Safety foods (TTC) need to be maintained at 41 degrees or below or 135 degrees Fahrenheit and above to prevent the growth of disease causing microorganisms that would be harmful to patients and others with compromised immune systems.

2. At 11: 00 AM, the temperature of the metal storage container in which the emergency supplies was stored was 82 degrees Fahrenheit. The highest temperature recorded for 07/07/15 in San Bernardino was 87 degrees Fahrenheit. (Accuweather.com) The outside temperature at 11:00 am was not as high as 82 degrees. FSD1 and FSD 2 stated in a concurrent interview that there no temperature logs or other monitoring of temperatures of the contents of the storage container.

According to the manufacturer's recommendation "for best results (longest shelf life and highest nutrition retention) we recommend avoid prolong storage at temperatures above 75 degrees Fahrenheit ... we do know there is depreciation in life span associated with prolonged storage above 75 degrees Fahrenheit." The average temperature of San Bernardino is 63 to 96 degrees with occasional highs of over 100 degrees Fahrenheit (US Climate data).

DS stated at 11:02 AM that the container could be equipped with an air conditioner and that emergency water was moved indoors due to high temperature concerns.

Based on observation, document review and interview, the facility failed to ensure a safe environment for their patients from fire. This was evidenced by not providing a reliable emergency back-up power to continuously supply electricity to their critical Life Safety Systems and failed to provide continuous illumination to their path of egress to ensure a safe evacuation. The failure of the emergency back-up power could result in failure to provide power to lights, and critical Life Safety equipment, including illumination to vital egress paths needed for a safe evacuation from the building to a safe location. One hundred seventy four patients, staff and visitors were affected by this deficient practice and could cause potential injury from lack of emergency back-up power.

Based on observation and staff interviews: 1) The hospital failed to ensure the food service equipment was maintained at an acceptable level of safety and quality. The temperature of the hot water in the hand washing sink in the kitchen was set at a level that would not result in injury to staff. There was no signage warning staff of this potential hazard. The dish machine leaked water in at least three areas, resulting in a pool of water all over the floor. This posed a risk of injury due to fall. In addition, the steamer in the kitchen must be maintained at an acceptable level of safety and quality. Each of the four doors of the steamer leaked water from its door and had staff utilized stainless steel pans to catch the drips; 2) The facility failed to ensure all medication refrigerators were maintained to ensure acceptable level of quality. As a result, medications were potentially stored in sub-optimal conditions.



Findings:



1. During hand washing on 07/07/15 at 10:15 AM and 11: 21 AM, the water felt hot to the hands. A check of the temperature at 11:24 am revealed the hot water was 123.3 degrees Fahrenheit.


Warm water is more effective than cold water in removing the fatty soils encountered in kitchens. ASTM Standards for testing the efficacy of handwashing formulations specify a temperature of 100 to 108 degrees Fahrenheit. (2013 Food Code)


Burns related to hot water may also be due to spills and immersion. The degree of injury depends on factors including water temperature, the amount of skin exposed and the duration of exposure. According to Time and temperature Relationship to serious burns table, water temperature at 124 degrees Fahrenheit could cause a third degree burn (a third degree burn is burn that injures the top layer of the skin, the fatty tissue and spreads into the muscles) to occur in three minutes. (Centers for Medicare and Medicaid, SOM)


This observation was shared with the food service director (FSD 1). She stated in a concurrent interview, she would have the maintenance department look into it.


At 2:17 AM on 07/06/15, a tour of the dish room revealed a pool of water all over the floor in the dish room. Inspection of the machine revealed water leaks dripping onto the floor in at least three areas. In an interview with the FSD 1 at 2:30 pm she indicated she was aware and that hospital management was aware and that replacement of the machine was being planned as part of the hospital ' s capital expenditure.


At 4:20 PM on 07/06/15, the steamer was observed with water streaming out each of the doors of the four steamers. Each door had a large stainless steel pan to catch the liquid flowing out of the doors. Each pan had varying amounts of water from inch to about three in it. FSD1 stated it was broken and could not remember how long ago it was broken. A kitchen supervisor (KS 2) stated during the same observation that she had worked in the kitchen for over a year and it had been that way as far as she could remember.


In an interview with the Facilities Maintenance Manager (FM) and Facilities Director (FD) on 07/09/15 at 7:45 AM, the both acknowledged the problems with the dish machine. According to FM the machine is old and leaks along the seams. He stated that the machine has been fixed several times. He stated that the plate warmer has been fixed and had no knowledge of problems with the steamers. Review of the work order for the previous six months showed that the dish machine had been repaired at least thirteen times, with "checking the leaks" being a recurring problem. The last work order was dated 07/03/15. One worker had "steamer" as a problem.


In an interview conducted at 11:00 AM on 07/09/15 with Vice President of Support Services, (VPS) indicated that she was aware of the equipment problems in the kitchen and that these equipment are being addressed at the capital committee for replacement this fiscal year.



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2. During an inspection of the medication storage area on 4 Tower East with Pharmacy Technician 1 (Tech 1) and the Director of Pharmacy (DOP) at 10:25 AM on July 8, 2015, the medication refrigerator had a note posted on the door reminding the users to close the door tightly to maintain the appropriate temperature due to a gap on the door. The maintenance record for the refrigerator was requested.


At 5:10 PM on July 9, 2015, the Quality Coordinator (QC) stated there were no maintenance records for the refrigerator in question, or other medication refrigerators not attached to the Automated Dispensing Cabinet (ADC). The QC further stated, these refrigerators were "run until fail," meaning if they would be used until they stopped working, then they would be replaced, and maintenance was not performed.

The hospital failed to ensure the Condition of Participation: CFR 482.42 Infection Control was met by failing to:

1. Ensure there was a system to identify unsanitary conditions in one of the walk-in refrigerators in the kitchen when kitchen staff did not clean the refrigerator in a manner to prevent overgrowth of mold on several insulation pipes. (Refer to A-0749)2. Ensure that kitchen staff monitor the temperature of leftovers and prepared items that were cooled. Improperly cooling is a major factor in causing foodborne illness. Foods that have cooked and held at improper temperatures promote the growth of disease causing microorganisms that may have survived the cooking process. (Refer to A-0749)


The cumulative effect of this systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: CFR 482.42 Infection Control.

Based on observation, interview and record review, the hospital failed to ensure, sanitary conditions were maintained in one of three refrigerators, the "Cook's" refrigerator, and potentially hazardous foods were properly stored in the refrigerator, within recommened temperature ranges. The failure to properly clean and monitor the temperature of the "Cook's" refrigerator enduced the growth of mold. These failures resulted in an immediate threat to the health and safety of the patients, in a universe of 174 patients.

Findings:

During an inspection of the kitchen on 07/06/15, at approximately 9:45 am, there was a strong musty smell inside the walk-in refrigerator. The dimly lit refrigerator was inspected using a flash light. Underneath the condenser, there were several pipes covered with black insulation. Patches of this white and black colored substance was seen sporatically along all pipe insulation. Addtionally, more if the black colored substance was observed on two of the walls and on the floor of the "Cook's" refrigerator.

During a concurrent interview with the Food service director (FSD), on 07/07/15, at 9:45am, she stated the "Cook's" refrigerator and the Foodservice Supervisor (EC) was responsible for ensuring the sanitation of the refrigerator.

During an interview with the EC, on 07/07/15, at 9:50 am, with the FSD present, the EC stated the refrigerator was cleaned daily and presented a copy of a document titled "Master Cleaning Schedule" which indicated the refrigerators were being cleaned. However, this document did not reflect a routine cleaning schedule for the "Cook's" refrigerator. Additionally, EC stated "The refrigerator was cleaned daily, even if it was not listed on the schedule." The document further indicated the date of "5/6", as the last date the areas on the list had been cleaned. EC and FSD did not provide any information indicating why the refrigerator was not cleaned, nor did they have a policy and procedure addressing the cleaning procedures for the refrigerators.

During a review of the kitchen's "Refrigerator Temperature Log" on 07/07/15, at 10:00 am, the temperature recorded was 47.6 degrees Fahrenheit. The recommended temperature for a refrigerator is below 41 degrees Fahrenheit.

During an interview with the DC, on 07/07/15, at 2:30 pm, when asked about the documentation of the temperature for the "Cook's" refrigerator on 07/07/15, at 10:00 am, recorded as 47.6 degrees, he stated he has not had any problems with temperature discrepancies for this refrigerator.

On 07/07/15, at 2:55 pm, a request was made for the facility laboratory to complete an analysis of the white and black substance located on the pipe insulation, the two walls and floor of the refrigerator. The completed analysis confirmed the substance was mold. Mold grows at all temperatures including 32 to 95 degrees Fahrenheit, but seems to thrive at 77 to 86 degrees Fahrenheith (Wikipedia.com).

The growth of mold which resulted in an immediate threat to the health and safety of the hospital patients, staff and visitors prompted an Immediate Jeopardy situation and was declared on 07/07/15 at 6:10 pm in the presence of the facility Chief Nursing Officer, Director of Quality Management, Director of Infection Control and Vice President of Support/Clinical Services.

A subsequent meeting at 6:59 pm with the facility administrators presenting their actions to remove the immediate jeopardy situation, included the following:

a. quarantine the refrigerator,
b. culture test the sportes (a small organism able to grow in the right conditions),
c. use a professional service for cleaning the refrigerator,
d. remove and replace the insulation on the piping, and
e. perform any needed repairs on the refrigerator unit.

During this jeopardy abatement conference the infection control nurse stated "the kind of mold found was a result of vegetables brought into the hospital, and that it posed no risk to staff and patients". The analysis of the different kinds of mold did not support the assertion it could not pose any risk to the staff, patients and visitors. Air sample analysis report indicated the presence of mold in two areas. She did not provide any information on how the infection control program failed to identify the problem.

On 07/08/15, at 4:10 pm the immediate jeopardy was abated.

A concurrent review of the laboratory analysis of the samples taken from the refrigerator tubing, metal, and air showed the presence of several types of mold. Some of the examples include basidiospores 3+, mold, phoma/coelmycetes mold, torula mold 2+ and clasdosporium 3+, Chaetomium 4+. (The numbers following the name of each fungus/mold shows the density (abundance). The higher the number, the more abundant it is.) According to the "Guidelines For Interpretation: ...Molds have been associated with a variety of health effects and sensitivity varies from person to person."

Basidiospores (a spore that reproduces itself) are a form of fungus similar to mushrooms found in areas with high humidity (moisture). The known disease conditions caused by Basidiospores include inflammation of the cornea in the eye, and pneumonia in patients who's body does not have the ability to respond normally to an infection. It may also cause hay fever, asthma and mushroom sensitivity.

Cladosporium is a common indoor and outdoor mold. It is olive green to black in color. The airborne spores of Cladosporium species are significant allergens, and in large amounts they can severely affect asthmatics and people with respiratory diseases. Cladosporium produce volatile organic compounds (VOCs) associated with odors. The strong musty odor in the refrigerator is a result of this mold. Chaetomium is one of those molds that require chronic moisture conditions for it to grow. Its presence is therefore an indication of existing or previous serious moisture problem.

Two of the requirements for mold growth are moisture and temperature. According to the University of Central Florida Infectious Control literature "most mold require a considerable amount of moisture for growth."

During an interview with the Facilities Management Director and the Facilities Manager, on 07/09/15, at 7:50 am, both indicated they do not have a record of problems with the refrigerator, but believe the deterioration of the insulation was due to the "sweating" of the pipes and this was a contributing factor in the growth of mold in the "Cook's" refrigerator.

Based on interview and record review, the hospital did not ensure that hospital policies and procedures were followed as the hospital did not ensure that:1. Patient 7 received adequate post-operative care when there was no documented evidence of a post-operative wound drainage assessment before patient was discharge.2. The surgical staff notified their supervisor when an incorrect sponge coundt occurrred at the end of a surgiical procedure.3. A left over, partially used, undated sterile water bottle was removed from the Or after the surgical procedure, and before the OR was cleaned for the nest patient.4. A sterilized laryngoscope blade was removed from the OR when sterility of the outer packaging had been compromised.5. The OR table pad was intact and easy to disinfect after each patient.

These practices increased the risk of substandard surgical care for all hospital patients.

Findings:

1. During a review of the clinical record for Patient 7, the History and Physical, dated February 18, 2015, indicated "Masses in bilateral (both sides) breasts,? etiology (unknown cause)... Recommendation Bilateral Breast... Biopsy (removal of tissue for analysis). "The Operative Note, dated February 19, 2015, indicated "Title of operation: Bilateral breast needle localization (to mark the area to be analyzed) with bilateral lumpectomy (removal of tissue for analysis)...We then came to the left side, and similarly incision was made ...Because of the large cavity, a #7 JP (Jackson Pratt) drain (to allow fluid to drain from the surgical site) was left ..." The Post Anesthesia Care Unit (PACU) record, dated February 19, 2015, indicated no documented evidence that the output (amount of fluid that drained out of the surgical wound) from the JP drain was assessed by the nursing staff before Patient 7 was discharged home.

During an interview with RN Unit Director 1, on July 8, 2015, at 8:55 AM, she reviewed the clinical record for Patient 7 and was unable to find documentation of the output from the JP drain before Patient #7 was discharged home. RN Unit Director 1 agreed that it was important for the nursing staff to have evaluated and documented the fluid drainage from the surgical wound (JP drain) before Patient #7 was discharged home. The RN Unit Director 1 confirmed that no causal analysis was performed regarding the post-operative care of Patient 7.

During a review of the clinical record for Patient 7, the Emergency Department Chart, dated February 20, 2015, indicated "Diagnosis Left Breast Pain." The Operative Note, dated February 20, 2015, (for the second operation) indicated " Preoperative Diagnosis Left breast hematoma (a solid swelling of clotted blood within the tissues) post lumpectomy (after breast tissue removal surgery)... A fairly large hematoma evacuated (removed) with the removing the large amount of blood clots that appeared to be close to about one unit (of blood) by gross estimation ... A #19 Blake drain was inserted ..."

During an interview with RN Unit Director 1, on July 8, 2015, at 8:55 AM, she reviewed the clinical record for Patient #7 and confirmed that Patient #7 returned to the facility Emergency Department one day after her surgery complaining of pain. She also confirmed that Patient #7 had to have a second surgery to remove a large quantity of blood that had accumulated in the surgical wound overnight.

The facility policy and procedure titled "Scopes of Services Post Anesthesia Care Unit " dated September 2014, indicated "As a division of Perioperative Services (services around surgery), it provides comprehensive immediate post-operative and post-procedural nursing care for inpatients and outpatients who have received general, regional and procedural sedation (medication to decrease pain and awareness during surgery)... Qualifications and Responsibilities of Staff ...Registered Nurse... Document clearly and concisely all aspects of care provided."

2. During a review of the clinical record for Patient #8, the Operative Note, dated December 23, 2015, indicated " Title of operation: Aortic valve replacement... The Nursing Operative Record, dated December 23, 2015, indicated " IC = Incorrect Count " was circled, "X-Ray Result-negative for foreign Body... "The Physician Progress Notes, dated December 25, 2015, indicated "POD#2 (post-operative day 2) "Sponge count was off in O.R. after chest was closed. Two X-Rays were taken in this 264 kb (kilo) patient with no sign of sponge. Count was still off yesterday after room was torn apart. CT scan (specialized X-Ray) of chest showed no definite evidence (of the sponge), however I am concerned ...Plan to O.R. for re-exploration (to look for missing sponge)." The Operative Note, dated December 25, 2015, (second operation) indicated " Preoperative Diagnosis: Possible retained Ray-Tec sponge status post aortic valve replacement ...Postoperative Diagnosis: Sponge between superior vena cava (the vein that carries deoxygenated- oxygen poor- blood from the upper half of the body back to the heart) and aorta (the main artery in the human body)."

During an interview with RN Unit Director 1, on July 8, 2015, at 9:15 AM, she reviewed the hospital ' s evaluation of the cause of the incident, which indicated that the nursing staff did not report the incorrect surgical sponge count to their supervisors at the end of surgery. Also during the interview with RN Unit Direct 1, she reviewed the clinical record for Patient #8 and was unable to find documentation that the O.R. circulator nurse reported the incorrect surgical sponge count to her supervisors at the time of surgery. She added that she was not notified of the incorrect sponge count at the time of surgery. RN Unit Director 1 stated that the circulator nurse should have notified the charge nurse, who should have notified the O.R. manager, who should have notified the O.R. Director of the incorrect surgical sponge count. She stated that if the O.R. leadership had been notified of the missing sponge at the time of surgery, the leadership would have entered the O.R. and recommended to the surgeon to re-explore the patient at that time.

The facility policy and procedure titled "Surgical Counts and Sponge Accounting" dated December 2014, indicated "In the instance of an Incorrect Final Count the charge nurse/manager will be notified."

3. During an observation on July 6, 2015, at 9:45 AM, in Operating Room (O.R.) four, a one liter bottle of sterile water was observed to be open undated and three-quarters empty. The bottle was found in O.R. four after the room had been cleaned in preparation for the next patient surgery. During a concurrent interview with RN Unit Director 1, she acknowledged the opened, undated and used bottle of sterile water and agreed that it should be removed from the O.R.

The facility policy and procedure titled "Medication Administration to Sterile Field " dated January 2015, indicated "All medication containers on/off sterile field will be kept in the O.R. Suite until conclusion of procedure."

4. During an observation on July 6, 2015, at 9:45 AM, in Operating Room (OR.) four, a short blade of a laryngoscope (instrument used to obtain a view of the vocal cords) was observed, wrapped in a sterile package that had a yellow water stain. This packaged equipment was stored in O.R. four and available for patient use. During a concurrent interview with RN Unit Director 1, she acknowledged the yellow stained packaged instrument and removed it from O.R. four to be re-sterilized.The facility policy and procedure titled, "Scopes of Services Post Anesthesia Care Unit" dated September 2014, indicated "Recognized Standards OR Practice Guidelines. Association of Perioperative Registered Nurse (AORN)."

AORN Recommended Practices for Sterilization, dated 2013, Recommendation XV.a, indicated "The shelf life of a packaged sterile irem should be considered event-related. Shelf life is dependent on packaging material, storage conditions, transport, and handling. An event must occur to compromise package content sterility. Events that may compromise the sterility of a package include... moisture penetration..."

5. During an observation on July 6, 2015, at 9:45 AM, in Operating Room (O.R.) four, the O.R. table was observed to have multiple one inch tears, in the O.R. table pad, where the patient is located during surgery. During a concurrent interview with RN Unit Director 1, she acknowledged the tears and quickly replaced the pad with a different, intact pad that would be easier to keep clean.

The facility policy and procedure titled "Scopes of Services Post Anesthesia Care Unit" dated September 2014, indicated " Recognized Standards OR Practice Guidelines. Association of Perioperative Registered Nurse (AORN)."

AORN Recommended Practices for Environmental Cleaning, dated 2014, Recommendation II,.h. indicated, "Mattresses and padded positioning device surfaces (eg. OR beds, arm boards, patient transport carts) should be moisture resistant and intact. Absorbent or non-intact surfaces may bccome reservoirs for microorganisms and may harbor pathogens. IIh.1 Damaged or worn coverings should be replaced.

Based on interview and record review, the hospital did not ensure Patient #7 received adequate post-operative care, according to acceptable standards of practice, when there was no documented evidence of post-operative wound drainage assessment before the patient was discharged. Patient #7 was returned to the O.R. the next day for drainage of a wound hematoma.

Findings:

During a review of the clinical record for Patient 7, the History and Physical, dated February 18, 2015, indicated " Masses in bilateral (both sides) breasts,? etiology (unknown cause) ...Recommendation Bilateral Breast ...Biopsy (removal of tissue for analysis). "The Operative Note, dated February 19, 2015, indicated " Title of operation: Bilateral breast needle localization (to mark the area to be analyzed) with bilateral lumpectomy (removal of tissue for analysis)...We then came to the left side, and similarly incision was made... Because of the large cavity, a #7 JP (Jackson Pratt) drain (to allow fluid to drain from the surgical site) was lef ..."The Post Anesthesia Care Unit (PACU) record," dated February 19, 2015, indicated no documented evidence that the output (amount of fluid that drained out of the surgical wound) from the JP drain was assessed by the nursing staff before Patient 7 was discharged home.

During an interview with RN Unit Director 1, on July 8, 2015, at 8:55 AM, she reviewed the clinical record for Patient 7 and was unable to find documentation of the output from the JP drain before Patient 7 was discharged home. RN Unit Director 1 agreed that it was important for the nursing staff to have evaluated and documented the fluid drainage from the surgical wound (JP drain) before Patient 7 was discharged home.

During a review of the clinical record for Patient 7, the Emergency Department Chart, dated February 20, 2015, indicated " Diagnosis Left Breast Pain. "The Operative Note, dated February 20, 2015, (for the second operation) indicated " Preoperative Diagnosis Left breast hematoma (a solid swelling of clotted blood within the tissues) post lumpectomy (after breast tissue removal surgery) ...A fairly large hematoma evacuated (removed) with the removing the large amount of blood clots that appeared to be close to about one unit (of blood) by gross estimation ...A #19 Blake drain was inserted ..."

During an interview with RN Unit Director 1, on July 8, 2015, at 8:55 AM, she reviewed the clinical record for Patient #7 and confirmed that Patient 7 returned to the facility Emergency Department one day after her surgery complaining of pain. She also confirmed that Patient #7 had to have a second surgery to remove a large quantity of blood that had accumulated in the surgical wound overnight.

The facility policy and procedure titled "Scopes of Services Post Anesthesia Care Unit " dated September 2014, indicated "As a division of Perioperative Services (services around surgery), it provides comprehensive immediate post-operative and post-procedural nursing care for inpatients and outpatients who have received general, regional and procedural sedation (medication to decrease pain and awareness during surgery) ...Qualifications and Responsibilities of Staff ...Registered Nurse ...Document clearly and concisely all aspects of care provided."

A-959
Based on interview and record review, the hospital did not ensure that two of 57 sampled patients (Patient 1, Patient 10) had a complete, accurate and scientific medical record. This practice increased the risk of a poor surgical outcome for all surgical patients.

Findings:

During a review of the clinical record for Patient 1, the Consultation Note, dated July 5, 2015, indicated" I started seeing him on July 5,2015, it looks like it is July 6, 2015 now, time just flies when you are having fun."

During a review of the clinical record for Patient 10, the Procedure Note, electronically signed on June 16, 2015, did not indicate the date after" Date of Procedure" and did not indicate the Preoperative Diagnosis (reason for procedure) or the Postoperative Diagnosis (results of the procedure), as they were both left blank. Review of the Discharge Summary (summary of hospital events), electronically signed on June 3, 2015, indicated " Date of Admission: May 29, 2015 but did not indicate the date after "Date of Discharge" (date patient left the hospital) as it was left blank.

During an interview with DMS, on July 9, 2015, at 7:40 AM, he reviewed the clinical record for Patient 1, including the Consultation Note, dated July 5, 2015. When he was asked about the quote "time just flies when you are having fun", which appeared in the patient's Consultation note, which is part of the permanent patient clinical record, he answered "I don't know if anyone is checking quality of the dictated notes."

During an interview with the DOQ on July 9, 2015, at 4:05 PM, she reviewed the evaluation of contracted services (quality information about services provided to patients by an outside company). When the DOQ was asked about the evaluation (of the quality) of the transcription service (the service that types up the doctor's dictated patient notes), she was unable to find documentation of a quality evaluation of the contracted service. The DOQ also reviewed the entire list of contracted services provided and was unable to find documentation of the transcription service on the list. The DOQ then explained "We don't do them all."

The hospital Medical Staff Bylaws, dated December 2014, indicated "The attending Practitioner shall be held responsible for the preparation of a complete medical record of each patient... No medical record shall be filed until it is complete... the attending Practitioner is responsible for furnishing a complete, accurate and scientific record."