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Based on observation and interview, the hospital failed to ensure emergency drug supply containers were sealed by pharmacists with a breakable seal in accordance with California Code of Regulations.

Findings:

California Code of Regulations Title 22 70263 (f) (2) stipulates that emergency drug supply shall be sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs.

During a tour of the surgery department at approximately 3:25 pm on 6/12/12, the emergency supply cart (crash cart) was inspected with the Operating Room Manager 1 (ORM1). Upon completion of the inspection, ORM1 sealed the crash cart with a plastic tie. ORM1 stated that crash carts in the hospital were sealed by registered nurses after restocking of the supply within.

During a tour of the emergency department at approximately 2:30 pm on 6/12/12, a locked storage box labeled "CLOT BOX" was observed above the emergency drug supply cart. Registered Nurse 2 (RN2) stated that the drugs and supply inside the clot box was for the emergency management of patients arriving at the emergency department with a heart attack. RN 2 used a key to open the clot box. RN 2 stated that the clot box was not sealed by a pharmacist.

Based on staff interview, and employee personnel file review, the facility failed to ensure that the supervisors of the medical record and dietary departments were credentialed in accordance with State regulations. These failures had the potential to result in:
1. the facility being at-risk by not being in compliance with laws and regulations on maintaining the privacy and security of health information.
2. patients receiving the wrong diet or developing foodborne illness due to the lack of department oversight by qualified personnel.

Findings:

1. California Code of Regulations, Title 22, section 70747(b) requires that the medical records services shall be under the supervision of a registered records administrator or accredited records technician. These titles are now known as registered health information administrator (RHIA) and registered health information technician (RHIT).

During an interview with the Director of Finance on the morning of 6/12/12, he stated that the facility has not had a credentialed supervisor for the medical records department since 4/23/11. A reorganization was done approximately 6 weeks ago, which gave him oversight of the department. DF1 stated that he does not have one of the required credentials, nor does the most senior staff person in the department, Health Information Manager 1.

During an interview with Personnel Manager on 6/13/12 at 11:30 am, she stated that the facility had only begun to advertise about one month ago for a Medical Records Manager with at least an RHIT credential.



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2. California Health & Safety Code 1265.4(b)(4) reads, "The dietetic services supervisor shall have completed at least one of the following educational requirements: Is a graduate of a dietetic services training program approved by the Dietary Managers Association and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility."

During a concurrent interview and facility document review, with the Dietary Manager (DM 1) on 6/11/12 at 2:40 pm, findings from two previous surveys of the dietary department conducted during 1/2011 and 5/2011 were reviewed. The dietary supervisor's lack of credentials were cited during both surveys. DM 1 reported that she had not been able to complete the education that was needed by 12/11. DM 1 reported that the facility had hired another individual within her department who possessed the proper credentials Dietary Supervisor (DS 2).

During an interview with DS 2 on 6/12/12 at 8:10 am, she confirmed that she graduated from a dietetic services training course approved by the Dietary Managers Association, but never took the certification exam. DS 2 stated that she was unaware that she needed to take the certification examination following the completion of her course.

Based on observation, interview, and document review, the facility failed to ensure that an emergency pericardiocentesis treatment kit (a kit used to assist in the removal of fluid collected in the sac/membrane surrounding the heart) was complete in the clean supply room on the medical surgical floor. This had the potential to delay the emergency treatment of any patient by requiring staff to gather the missing items from individual floor stock or obtain a kit from another area of the facility. The facility also failed to appropriately store laboratory supplies in a manner that would protect others from dirty or expired items. These failures in regards to equipment storage and/or treatment had the possibility of affecting the health, safety, and lives of the patients.

Findings:

1. During an observation on 6/11/12 at 11 am, the clean supply room,on the medical/surgical unit, was inspected with the emergency room charge nurse (RN 1). A large, clear plastic bag labeled "pericardiocentesis kit" was found in a bottom cabinet. The bag contained a list that identified items that were to be in the kit. The only listed items in the bag were two rolls of tape and a 25 gauge butterfly Vacutainer blood collection set. All other items on the list were missing. Six extension tubings for intravenous lines and one package of Ethicon FS-2 surgical suture, items that were not included in the list, were also stored in the bag.

During a concurrent interview, RN 1 verified the pericardiocentesis kit was not complete. When asked who checked the stocked supplies, RN 1 stated, the floor staff check the supply room for outdated items but did not remove the pericardiocentesis kit bag because they have never used it.



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2. On 6/12/12 at 9:45 am, the laboratory department was inspected with the Laboratory Manager (LM) 1 and the Director of Pharmacy (Pharm 1). An unused blood collection tube, with old and encrusted blood on the outside surface, was found in the mobile tray used for drawing blood outside the lab. Approximately twenty agar culture plates, used to culture microorganisms, had expiration dates in 5/2012, and were available for use in the laboratory fridge. LM 1 and Pharm 1 acknowledged and confirmed both findings in the laboratory department.

Based on observation, interview, and document review, the facility failed to ensure the hydrometer, used to measure the temperature and humidity of the operating room, provided accurate readings, and failed to address readings that were out of an acceptable range. Temperature, humidity and airflow in the operating rooms must be maintained within acceptable standards to inhibit bacterial growth and prevent infection, and promote patient comfort. Excessive humidity in the operating room is conducive to bacterial growth that could result in contamination of equipment and infections for surgical patients.

Findings:

According to the American Operating Room Nurses (AORN) Association perioperative standards, humidity levels in the operative suite should be between 30 - 60% and the temperature should range between 68 and 73 degrees Farenheit.

During an observation on 6/12/12 at 12 pm, the hydrometer on the wall of operating room one read, humidity 24 % and the temperature was 64 degrees Farenheit.

A review of the operating room temperature and humidity log from 1/2012 through 6/12/12, showed that the humidity was consistently below 30 %. In January 21 of 21 days were less than 30 %, February - 20/21 days, March - 19/22 days, April - 14/21 days, May 11/22 days, and June 1/9 days.

During an interview on 6/13/12 at 1 pm, the Manager of Engineering (ME 1) stated, there was no way to calibrate the non-commercial grade hydrometer in the operating room. ME 1 obtained another hydrometer, placed it on another wall of the operating room, and the humidity reading was 50 %. ME 1 stated, the facility did not routinely change the hydrometer, and evidently, it was not working properly.

Based on observation, interview, and document review, the facility failed to ensure the premises was free from dust and dirt. The presence of dirt and dust in patient care and supply storage areas could lead to the contamination of supplies, and promote infection and/or bacterial growth for patients.

Findings:

1. On 6/11/12 at 11 am, an inspection of the clean supply room on the medical surgical floor was conducted with the emergency room charge nurse, (RN 1). During the inspection two patient scales were observed with dirt on lower platform and dust around the upper weight bar area of the scales.

During a concurrent interview, RN 1 verified the presence of the dirt and dust and stated that housekeeping was responsible for cleaning the equipment.

During document review on 6/13/12, the Policy and Procedure for Housekeeping (Environmental Services), last reviewed 11/12/08, indicated the routine cleaning of horizontal surfaces was to be done daily and more frequently if visible soiling occurred.

2. On 6/11/12 at 3 pm, an inspection of Room 308, on the labor and delivery (obstetrics-OB) hall, was conducted with the OB supervisor/charge nurse, (RN 2). Room 308 had 2 empty beds and no patients assigned to the room. When the bathroom was entered for inspection a strong, foul odor was noted, the window was open and approximately one to two dozen gnats had entered the room.

RN 2 stated that someone had used the restroom and opened the window allowing the bugs to enter. When asked if the restroom would have been routinely cleaned prior to a patient arriving in the room, RN 2 stated, "No."

3. On 6/12/12 at 7:30 am, an inspection of the emergency room and equipment was conducted with the emergency room charge nurse (RN 1). A base layer of dirt and loose top layers of dust covered an empty wall mounted temperature probe holder, an electronic temperature probe and it's wall holder, a mounted wooden strip for electric plugs across the back wall and it's upper edge, and on top of an I.V. (intravenous-into a vein) pump connected to an I.V. pole next to a gurney.

During a concurrent interview, RN 1 stated that the emergency room was cleaned by the emergency room (ER) technicians (techs) and not by housekeeping. RN 1 stated that the ER techs were actually the paramedics and emergency medical technicians (EMT's) and that they worked in the ER when not doing ambulance runs.

When asked for the Policy and Procedure (P&P) for cleaning of the ER, RN 1 provided the Housekeeping (Environmental Services) P&P's for routine cleaning in patient care areas, and a policy for periodic deep cleaning of the facility that did not include the ER. When asked if there was a P&P specifically for the cleaning of the ER, RN 1 stated, "No."

During an interview on 6/14/12 at 11:50 am, the environmental services manager (ESM 1) stated that the housekeeping staff are not allowed to do daily or periodic deep cleaning of the ER.



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4. During an observation of the dietary services department (kitchen) on 6/11/12, starting at 11:05 am, all over head vents were noted to have visible dark material at all corners. During an interview on 6/11/12 at 11:30 am, Dietary Services Supervisor (DS) 2 acknowledged that all of the over head vents in the dietary service department had visible dark material at all corners and were in need of cleaning.

5. During a tour of the CT (computed tomography, a type of x-ray) Scanner located in an out building adjacent to the facility on 6/12/12 at 9:30 am with Radiology Technician (RT 1) and the Director of Pharmacy (Pharm 1), a large amount of spider webs were noted in the top corner of the ceiling. Pharm 1 and RT 1 confirmed this finding and both stated that the cobs webs needed to be addressed.

During an interview with the Environmental Services Manager (ESM) 1 on 6/14/12 at 11:45 am, she acknowledged the spider webs and reported that the facility does not have a policy and procedure which directly addressed the cleaning of the CT facility.

Based on staff interview and document review, the Governing Body (GB, Board of Directors) failed to ensure that the hospital policies and the medical staff bylaws and rules were followed so as to provide quality health care in a safe environment. This has the potential to lead to under-qualified practitioners acting in a manner contrary to established standards of care and putting patients and staff members at risk of poor outcomes.

Findings:

1. On 6/11/12 the hospital was given a list of requests that included the medical staff bylaws and rules as well as the minutes of all general medical staff meetings and all medical staff committee meetings. On 6/12/12 at 10 am, the Medical Staff Secretary (MSS) provided the requested documents. On 6/12/12 and 6/13/12 the medical staff bylaws (MS Bylaws) and rules (MS Rules) were reviewed. On 6/12/12 the minutes of the minutes of the Medical Executive Committee (MEC) were reviewed.

In the MS Bylaws, Article VII, section 7/01-1 "Regular Meetings" states "There shall be four Staff meetings per year. One of these meetings shall be designated as the 'Annual Medical Staff / Administration / Board Retreat.' "

In the MS Rules, the subsections of Rule VII specifies 11 standing committees, there composition, purpose, "accountability and relationships". The listed standing committees are 1) Credential Committee; 2) Emergency Care and Trauma / Outpatient Services Committee; 3) Ethics Committee; 4) Health Information Management Committee; 5) Infection Control Committee; 6) Interdisciplinary Practice / Allied Health Professionals Committee; 7) Medicine, Pharmacy, Therapeutics and Pain Management Committee; 8) Obstetrical Committee; 9) Physician Well-Being Committee; 10) Quality Improvement / Risk Management / Utilization Review Committee; and 11) Surgical Committee. Each subsection specifies the frequency of meeting. For seven, the text states the committee "will meet on an as-needed basis." The other four read as follows: "The Emergency Care and Trauma / Outpatient Services Committee will meet at least four times per year"; "The Infection Control Committee will meet on at least a quarterly basis"; "The Medicine, Pharmacy, Therapeutics and Pain Management Committee will meet four times per year"; and "The Quality Improvement / Risk Management / Utilization Review Committee will meet at least six times a year."

During the afternoon of 6/12/12 the bimonthly minutes of the MEC from January 2011 until present were reviewed. There were no minutes of the general medical staff meetings and no minutes of any standing medical staff committee meetings to review. For each MEC meeting, the minutes contain a section labeled "Departmental / Committee Reports" under which the names of the eleven standing committees are listed. Most often these names stand alone with no additional information. Occasionally one or more listed committees had one or more bulleted phrases under the name. The meeting minutes corresponding to these bullets were again requested but none were available. On 6/12/12 at 3:15 pm, the MSS explained that these bulleted phrases only represented information provided by the MEC members, and did not indicate that a committee meeting had taken place. She also explained that there were only the MEC minutes because there had been no meetings of the general medical staff and no organized meetings of any standing medical staff committees.

On 6/13/12 during an interview beginning at 8:40 am, the current Vice-Chief of the medical staff (Physician 1) acknowledged that over that past several years (including from 1/1/11 to date) there had been no general medical staff meetings and no formal medical staff committee meetings. He explained that this occurred because the hospital had a very small number of physicians who participated in meetings, and only rarely was a quorum of two members present. He also explained that for the MEC meetings, any physicians or allied health professionals that were present in the hospital were invited to participate with voting status.

Physician 1 further explained that the standing committees' duties were most often taken care of by a member of the MEC, most often the committee chairperson, conferring with one or more available hospital staff members. For example, the credential committee's work was done by having the MSS compile the credential files for members up for appointment or reappointment. When these files were complete they were given to the Chief of Staff who is designated as the chairmen of the committee. The Chief of Staff then reviews the file(s), signs the necessary documents and gives a report during the next MEC meeting. All of this is done informally and minutes are not kept.

When portions of the bylaws and rules were referenced, Physician 1 acknowledged that he was not conversant with the MS Bylaws and MS Rules. Specific area were those that specify:
1. that general medical staff meetings were required at least four times yearly [MS Bylaws 7.01-1];
2. the composition of the MEC and who may vote [MS Bylaws 6.07-1];
3. that minutes were required for all medical staff meetings [MS Rules, Rule VIII-3]; and
4. that physicians may only be granted "Active Staff" membership after they "have completed their (one year or more) Provisional Staff term(s) satisfactorily." [MS Rules, Rule III-2]
In conclusion, Physician 1 also acknowledged that the MEC had not been discharging these duties in accordance with the MS Bylaws and the MS Rules.

2. During the afternoon of 6/12/12 and the morning of 6/13/12 the minutes of the MEC and selected medical staff credential files were reviewed. The minutes of the MED for 2/8/12 contained information that six emergency room physicians were currently applying for medical staff privileges. Of these, five (Physicians 2, 4, 5, 6, 7) had been recommended to the GB for Active Staff status and one (Physician 3) had not been recommended for membership. On review of credential files it was noted that these six relatively new medical staff members, had each been granted temporary privileges and had never been given provisional staff status. Each of the six files contained documentation that they had been given Active Staff status during the 2/22/12 GB meeting.

Rule 3 of the MS Bylaws requires that in order to be qualified for Active Staff status, the physician must satisfactorily complete a one year term as a Provisional Staff member. None of the six credential files explained how the physicians had not been required to complete the required prerequisite year as a provisional staff member. There also was no explanation as to how Physician 3 had been granted active medical staff membership in the absence of receiving a favorable recommendation from the MEC.

Review of Physician 3's credential file showed that he was not board certified, had not completed a residency for emergency medicine or for any specialty and therefore was not eligible for board certification. His credential file contains an AMA (American Medical Association) certificate listing his education, training, board certification and board eligibility. The AMA certificate verifies that Physician 3 had not completed any residency training, did not have a board certification and was not eligible to apply for board certification. The copy of the MS Bylaws that had been provided for review states in Article II, section 2.02-1(d) that in order to be qualified for any medical staff membership, the physician applicant must "be board certified in his/her field, or have completed a residency in a program approved by the Accreditation Council for Graduated Medial Education, which program provided complete training in the specialty or subspecialty that the Practitioner will practice in the Hospital; or have practiced in his/her field in a hospital accredited by the JCAHO for 10 consecutive years. Practitioners who do not meet one of the foregoing criteria in this Section 2.02-1(d), but who can produce documentation of having completed all prerequisites for board certification except passage of the board certification examination, will be deemed to satisfy this basic condition; provided, however, that such Practitioner must actually achieve board certification within two years of the date of submission of his/her initial application for Medical Staff membership in order to be eligible to apply for reappointment."

On 6/13/12, when Physician 1 was interviewed, he explained that on 6/21/12, after further another review of Physician 3's credential file, he had belatedly signed the required form that allowed Physician 3 to be considered for appointment at the GB meeting that was scheduled for the following day, 6/22/12. He further explained that he thought the bylaws had earlier been modified to take out the alternative requirement that a physician applicant may use 10 years of consecutive practice in a JCAHO hospital. He also stated he had the impression after reviewing the credential file that Physician 3 did hold a board certification. When Physician 3's AMA profile was pointed out to him Physician 1 agreed that Physician 3 did not hold board certification.

During the interview of Physician 1, the MSS looked for and found another version of the MS Bylaws in which section 2.02-1(d) had been modified effective as of July 1, 2011. She had no explanation as to how it occurred that the outdated version had previously been provided for review. The July 1, 2011 version of section 2.02-1(d) states: physician applicants must "be board eligible or board certified in his/her field. Practitioners who do not meet the foregoing criteria in this Section 2/02-1(d), but who can produce documentation of having completed all prerequisites for board certification except passage of the board certification examination, may be granted privileges by the Medical Staff Executive Committee on a case by case basis."

Physician 3's credential file contains no evidence of having completed any of prerequisites for board certification. According to the American Board of Emergency Medicine (found at www.abem.org or ) the only way to become eligible for board certification is by "the successful completion of an ... accredited residency program in Emergency Medicine."

According to the MS Bylaws, Preamble (page 4) "the Bylaws address the Medical Staff ' s responsibility to establish criteria and standards for Medical Staff membership and privileges and to enforce those criteria and standards ..."

On 6/13/12 during the interview that began at 8:40 am, and after it had been clarified which version was the current MS Bylaws, Physician 1 stated that he had thought Physician 3 did have a board certification.

Based on observation, interview, and record/document review, the facility failed to have effective systems in place provide an environment that was safe, informational, and met the needs of all patients as evidenced by:

1. No development of a written policy that described the services furnished by the hospital and those services furnished by outside providers. ( Refer to C 273)

2. The storage and distribution of drugs were not in accordance with accepted professional principles. (Refer to C 276)

3. The Infection Control System did not identify the increased risk of infection and contamination related to surgical staff that accessed an emergency exit door in the surgical suite routinely and contamination of a endoscopes inside a storage cabinet. (Refer to C 278)

4. Dietary services were not provided in accordance with recognized dietary practices. (Refer to C 279)

5. The hospital did not maintain a comprehensive list of all services furnished under arrangements or agreements. (Refer to C 291)

6. The nursing staff did not meet the needs of all patients. (Refer to C 295)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide patient services in a safe and effective manner in accordance with the statutorily-mandated Condition of Participation - Provision of Services.

Based on staff interview and document review, the hospital failed to develop an accurate, written policy that included a description of the services furnished directly by the CAH staff and also those services furnished through an agreement or arrangement by an outside provider. This had the potential to lead to patients and staff being confused about who was responsible for various services.

Findings:

On 6/13/12 and 6/14/12, the "Chief Nursing Officer, Acute" (CNO2) and the Chief Clinical Officer (CCO) were asked to provide the policy or policies developed by the hospital to comply with this section of the regulation. Specifically requested was a list and description of those patient care services provided directly by the hospital staff and those services provided under contract by outside providers.

During an interview on 6/13/12 at 2:45 pm, CCO pointed out in the Pharmacy policy binder a Policy and Procedure (P/P) titled "Scope of Service, Pharmacy." CCO stated that each department had a similar P/P in its departmental policy binder. The Scope of Service, Pharmacy P/P did contain a general description of many of the types of services provided by the Pharmacy, however, it did not contain a list of any services provided by outside providers and it did not contain a detailed listing of all the services provided by the Pharmacy. At the conclusion of this interview, CCO acknowledged that these policies did not contain any specific information about services furnished through agreement.

On 6/14/12 at 10 am, the CNO2 provided nine similar Scope of Services Policies and Procedures for various departments (Emergency, Obstetrical, Surgery, Radiology, Outpatients, Medical Staff, Purchasing, Health Information and Medical/Surgical). Each contained a general description of services provided, however, they did not contain a list of any services provided by outside providers, and did not contain a detailed listing of all the services provided by those departments. Also provided during this interview was a P/P titled "Critical Access Hospital: Provision of Services" dated effective 2/1/06. The P/P contained a short list of seven general services provided. However, the listing was incomplete and out dated. An example of this P/P being out dated is the statement, "(Name of hospital) provides outpatient surgical services for general, orthopedic and obstetric surgery." At present, general and orthopedic surgeries are not being done at the hospital. An example of a service provided which was not listed in the P/P is Dietary Services.

At 10:50 am on 6/14/12, CNO2 acknowledged that she could not provide a P/P or a group of P/Ps that described all of services furnished directly by hospital staff and those services furnished through agreement or arrangement.

Based on observation, interview, and document review, the hospital failed to ensure that the storage, and distribution of drugs were in accordance with accepted professional principles as evidenced by:

1. Failure to ensure the proper temperature monitoring of medications in the medication storage refrigerators.
2. Concentrated magnesium sulfate, a high risk medication, was stored in the emergency department as a floor stock.
3. Nitroglycerin for intravenous use, an emergency medication, was missing from the "clot box" emergency drug supply.
4. An opened multi-dose medication vial with no beyond-use date was found among the recovery room medication supply.
5. Bulk containers of concentrated morphine sulfate oral solution, an opiate medication for pain relief, were stocked in the automated dispensing cabinet with no safeguard in place to minimize errors.
6. Expired medications were available for patient use in the operating room.

Findings:

1. During a tour of the emergency department with Registered Nurse 2 (RN2) at approximately 2:30 pm on 6/12/12, the medication storage refrigerator was inspected. Various vaccines and medications were stored in the refrigerator. RN 2 stated that the temperature of the medication storage refrigerator in the emergency department was remotely monitored by the pharmacy.

During an interview at approximately 3 pm on 6/12/12, the hospital Chief Clinical Officer (CCO) stated that the emergency room refrigerator temperature was monitored by Pyxis (an automated dispensing cabinet system) which would prompt the pharmacist on duty if the emergency room refrigerator temperature was out of range. The CCO acknowledged that since the pharmacy was closed on Saturdays and Sundays, the refrigerator temperature of the emergency room was not being monitored on those days.

Exposure of vaccines to temperatures outside the recommended ranges can affect potency adversely, thereby reducing protection from vaccine-preventable diseases. CDC (the Center for Disease Control) publication, Guidelines for Maintaining and Managing the Vaccine Cold Chain read, "Proper temperature monitoring is crucial to proper cold chain management. Thermometers should be placed in a central location in the storage unit, adjacent to the vaccine. Temperatures should be read and documented twice each day, once when the office or clinic opens and once at the end of the day."

During an inspection of the surgery department with Operating Room Manager 1 (ORM1) at approximately 3:25 pm on 6/12/12, the temperature log of the medication storage refrigerator was reviewed. The temperature log showed that from 1/1/12 to 6/12/12, the recorded temperatures were all between 24 degree Fahrenheit to 28 degree Fahrenheit with no recorded temperature on all Saturdays and Sundays. The listed proper temperature range on the temperature log was 36 to 46 degree Fahrenheit. ORM1 stated that the surgery department was not open on weekends, therefore, the refrigerator temperature was not monitored on Saturdays and Sundays. ORM1 confirmed that all the recorded temperatures from 1/1/12 to 6/12/12 were out of range for proper medication storage and stated that the out of range temperatures were not reported to her and the department had not taken any action to address the issue.

During an inspection of the medication storage refrigerator in the surgery department at approximately 3:25 pm on 6/12/12, the refrigerator thermometer was showing a temperature of 26 degree Fahrenheit. All of the medications in the refrigerator were in their liquid forms suggestive of a non-freezing temperature inside the refrigerator. ORM1 stated that the thermometer was not recording the right temperature and needed to be replaced.

During an interview at approximately 10:30 am on 6/13/11, the hospital Chief Clinical Officer (CCO) acknowledged that the refrigerator temperature in the surgery department was not properly monitored. The CCO also stated that the temperature log was not routinely reviewed by the pharmacy during the monthly inspection.

2. During an inspection of the medication storage cabinet in emergency department, one 10-ml (milliliters) vial of magnesium sulfate 50% for injection was found among the active medication supply in the medication cabinet. RN 2 stated that the vial of magnesium sulfate was part of the emergency department floor stock, but she wasn't too sure of the usage of the product as premixed magnesium was available which did not require admixing.

During an interview at approximately 3 pm on 6/12/11, the hospital CCO stated that he was surprised to hear that concentrated magnesium sulfate was found in the emergency room. CCO added that magnesium sulfate 50% should not be stocked in patient care unit for patient safety reasons and also because that premixed magnesium sulfate products were available in Pyxis.

The Institute for Safe Medication Practices (ISMP), a nationally recognized nonprofit organization devoted to medication error prevention and safe medication use, has identified magnesium sulfate as one of the high alert medications. High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients.

The American Society of Health-System Pharmacist (ASHP) published guidelines, Minimum Standard for Pharmacies in Hospitals read, Floor stocks of medications generally shall be limited to medications for emergency use and routinely used safe items (e.g., mouthwash, antiseptic solutions). The potential for medication errors and adverse effects must be considered for every medication allowed as floor stock.

3. During an inspection of the emergency department "CLOT BOX" (a specific box containing an emergency drug supply used for the management of heart attack patients) with RN 2, one bottle of nitroglycerin 50mg/250ml premix solution for intravenous use was listed on the content list, but was missing from the supply box.

Nitroglycerin is a potent vessel dilator (open up blood vessels) that is used to increase blood flow to heart muscle during a heart attack and to lower blood pressure.

4. During an inspection of the medication storage cart in the post-operative recovery unit with ORM1 at approximately 3:35 pm on 6/12/12, one opened 20-ml vial of labetalol 5mg/ml was found in one of the drawers with no opening date or beyond-use-date on noted on the container. ORM1 stated that it was the hospital policy that medication vials are appropriately dated when first opened.

5. During an inspection of the Pyxis machine (an automated drug dispensing cabinet), two 30-ml bottles of morphine sulfate 100mg/5ml (20mg/ml) were observed in one of the storage compartments. There was no high risk/high alert or specific labeling or stickers on the bottles to alert nursing staff to exercise extra caution when administering the medication. Registered Nurse 3 (RN3) stated that the concentrated morphine solution was there for nursing staff to draw up individual doses for patients.

Morphine sulfate is a potent opiate pain medication for the management of moderate to severe pain. Oral morphine solution is available in different concentration ranging from
10mg/5ml (2mg/ml) to 100mg/5ml (20mg/ml). In January 2011, the FDA (Food and Drug Administration) and Roxane Laboratories (a drug manufacturer) notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the high potency 100 mg/5mL product. In most of these cases, morphine sulfate oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product.

The American Society of Health-System Pharmacist (ASPH) published guidelines "Safe Use of Automated Medication Storage and Distribution Device" indicates that automated medication storage system or device should provide safety features of unit dose distribution systems where medications are contained in, and administered from, a single unit or unit dose packages.

6. During an inspection of the anesthesia cart in the surgery department with Certified Registered Nurse Anesthetist 1 (CRNA1) at approximately 1:40 pm on 6/12/12, two 1-ml vials of oxytocin 10 units /ml with expiration date of 4/2012 were found among other active medication supply. CRNA1 confirmed that the identified medications were expired and were not suitable for patient use.
A review of the hospital policy and procedure on medication storage showed that expired medications should be removed from active supply and not be available for patient use.

Based on observation and interview, the facility failed to ensure that the infection control system identified breaches in infection control/prevention practices.
1) A door in the surgical suite, that had direct access to the outside, was being used to take trash outside. The opening of a outside access door for other than emergency purposes would allow dirt, debris, bugs, and air contaminants to enter the surgical suite increasing the possibility of infection.
2) Endoscopes tips rested on a towel that absorbed fluid that drained from the scopes following cleaning. The scopes and towel were in a closed cabinet; this dark, moist environment has the potential to promote bacterial growth and contamination.

Findings:

1. On 6/12/12 at 12 pm, the operating suite of the facility was inspected with the operating room manager (ORM 1). Two operating suites were at the end of the hall with the scrub sinks outside of Room 2. Behind the scrub sinks was a wall that separated a short hallway from the operating rooms but was not closed off with a door. At the end of this hallway (approximately 10 feet) was an unmarked door that had a push rail across the center that would allow staff to open the door. There was also a small metal hook device that would allow staff to hook the rail into an unlocked position to regain entry into the surgical suite area. A handle on the outside of this door allowed no entry into the surgical area unless opened from inside or the rail being hooked in the unlocked position. The two surgical rooms were approximately within 20 to 30 feet of this door.

During an interview on 6/12/12 at 1:30 pm, the housekeeping staff member for the operating rooms (ES 1) stated she uses the door to go outside and empty the trash after cleaning the operating rooms. When asked if they have had any problems with bugs ES 1 stated that gnats had gotten in the night before because there is a light right outside the door.

During an interview on 6/12/12 at 1:40 pm, ORM 1 stated that the door was part of the facility emergency evacuation plan and could not be sealed.

2. On 6/12/12 at 1:10 pm, an inspection of the clean endoscope (long flexible tube that enters the mouth and extends to examine the throat, stomach and upper intestine areas) and colonoscope (a long tube flexible tube introduced into the colon/rectum to examine the lower bowel areas) cabinet was conducted with ORM 1. The cabinet was closed with a white towel at the base and it was observed that a colonoscope had approximately one half inch of the tip of the tube resting on the white towel thus contaminating the tip after it had been cleaned.

When asked what the towel what used for ES 1 stated it was placed to soak up the alcohol that was used as the final stage in cleaning the scopes. ES 1 also stated the towel was changed once a week.

Based on observation, staff interview, and document review the hospital failed to ensure the in-patient dietary services were provided in accordance with recognized dietary practices, when the food and dietetic services was not organized, directed, and staffed in such a manner to ensure that the nutritional needs of the patient were met as evidenced by:

1. Lack of a comprehensive nutritional analysis of the hospital menus,

2. Lack of sanitary practices as evidenced by deficient practices in the recording of the cooked food cool down log,

3. Lack of qualifications as required by state law related to the dietary services supervisor and/or dietary manager,

4. Lack of proper preventive cleaning and maintenance of overhead vents in the dietary services department (kitchen),

These failures placed patients at risk for developing food borne illness and not meeting their nutritional needs.

Failure to develop comprehensive systems in dietetic services and nutrition care may result in compromising patients' nutritional and medical status.

Findings:

1. During an interview on 6/12/12 at 2:50 pm with Registered Dietician (RD 1), the hospital's nutrient analysis for the regular and therapeutic diet menus was requested. She reported that this information was not readily available at this time. RD 1 acknowledged that she had developed and approved the menus and that with the current format it would not be possible to determine whether the menus met the nutritional needs of patients. RD 1 further acknowledged that the menus used were not evaluated for the complete array of macro and micro nutrients specified by the Food and Nutrition Board of the National Research Council.
In addition, the 4 week menus cycles were not reviewed to ensure they met the current Recommended Dietary Daily Allowances (RDA) or the Dietary Recommended Intakes (DRI).

2. During a concurrent interview, and facility document review, on 6/11/12 at 11:30 am, Dietary Supervisor (DS) 2, was asked about the practice of cooking meat ahead of service. She stated that the meat was cooked and then placed directly in the middle of the freezer on an ice bath and the temperatures recorded on the facility's temperature log sheet.

During a review of the facility's temperature log sheets, it was noted that a new sheet for 6/2012 had not been started. DS 1 confirmed this finding and stated that a new log sheet should have been initiated, especially considering that multiple items have been cooked since 6/1/12 that would have required temperature documentations.

During a review of the facility's undated policy and procedure, titled, "Food Safety," read; "Internal temperature of meats should be 165 F before taking them out of the oven. Please monitor time/temperature of meats during the cooling process with the form (temperature log sheet)..."

The FDA Food Code 2009, the standard in the industry, requires potentially hazardous food, like cooked meat, be cooled requiring a two-step cooling process. The first step is from 135 degrees F to 70 degrees F within 2 hours and then from 70 degrees to 41 degrees F in 4 additional hours. There is serious potential for food borne illness when cooked foods are held in the danger zone (135 degrees F to 41 degrees F) when pathogenic microorganisms can grow. The FDA cool down program is intended to prevent potential food borne illness.

3. During a review of the Dietary Service Supervisor and the Dietary Manager's credentials on 6/12/12, there was no evidence of the appropriate amount of training to meet the state educational requirements. (Refer to C 152).

4. During a concurrent observation and interview, on 6/11/12 at 11:30 am, with DS 2, she acknowledged that all of the over head vents in the dietary service department had visible dark material at all corners and were in need of cleaning. (Refer to C 225).

Based on staff interview and document review, the hospital failed to maintain a comprehensive list of all services furnished under arrangements or agreements. The partial list that was kept did not contain a full description of the nature and scope of the services provided. This list is needed to assure all contracted services are regularly reviewed for quality. An incomplete or flawed list could lead to patients receiving under-qualified services.

Findings:

On 6/11/12 the hospital was asked to provide a comprehensive list of all services furnished, to the hospital or its patients, under arrangements or agreements.

On the morning of 6/12/12, a list of contracted services was provided in the form of a spread-sheet. At 10 am, the provided spread-sheet was initially reviewed and the MSS commented that the list was kept by the Executive Assistant to the Board of Directors (EAB1). For many of the listed contracts there was a short phrase under the column labeled "Contents." Some of the Contents phrases were information about the contract. Many contracts had nothing listed and many had a short acronym in the contents column. A translation of the acronyms was not provided. None had a full description of the nature or scope of the services provided.

On the afternoon of 6/13/12, the list was again reviewed and it lacked inclusion of two of three contracted services used by the Health Information Management Department (the remote coding service and the photocopy company that processed some of the legal requests for copies of medical records).

On 6/14/12 at 10:30 am during an interview, EAB 1 acknowledged that the list was incomplete and did not contain a full description of the nature and scope of the services provided by contract.

Based on observation and interview, the facility failed to ensure that nursing staff met the needs of one patient in the sample (Patient 19). Grip slippers were not provided to barefooted Patient 19 when she needed to walk to the bathroom. The lack of protective slippers could possibly have led to the patient falling and being injured.

Findings:

On 6/13/12 at 7:15 am, a review of admission documentation indicated that Patient 19 was admitted to the facility on 6/13/12 for an out-patient surgical procedure.

During an interview on 6/13/12 at 7:30 am, Patient 19 stated that she had a stroke that left her with residual paralysis of her right leg and weakness in her right arm

On 6/13/12 at 7:45 am, Patient 19 told staff nurse (RN 4) that she needed to go to the restroom before going into the surgical suite. As RN 4 uncovered Patient 19 it was noted that Patient 19 was barefooted. A wooden step stool, without grip strips, was placed below Patient 19's feet and as RN 4 and a friend of Patient 19 were trying to assist her to stand on the stool Patient 19's right foot kept sliding off the stool and Patient 19 stated, "Oh, that's slippery."

During an interview on 6/13/12 at 7:55 am, RN 4 was asked if the slippers with the grips on them were part of the normal outpatient garments provided to the patient for surgery. RN 4 stated that most patients wore their own socks.

During an interview on 6/13/12 at 8:20 am, the operating room manager (ORM 1) stated that the gripper slippers were part of the garments provided for the preoperative patients and should have been placed on Patient 19 as soon as it was known that she was barefooted.

Based on document review and staff interview, the facility failed to ensure that policies and procedures for the Health Information Management department (HIMD) were reflective of current practices, and that four (4) of four (4) employees had annual performance evaluations.

Findings:

1. The HIMD policy and procedure (P & P) manual was reviewed beginning on the afternoon of 6/11/12. The manual had an approval page signed on 1/12/12 which was to indicate that all the policies had been reviewed and were current. However, upon discussing some policies with Health Information Manager 1 (HIM1), she confirmed that they were not reflective of actual practices, such as the policies on transcription, subpoena processing and destruction of medical records; and there were no policies to address the outsourcing of both the coding and release of information functions.

In addition, the facility has at least seven (7) separate policies relating to medical record documentation and completion requirements. The two policies, "Physician Orders--Verbal and/or Telephone" effective 2/26/07, and "Physician's Orders" last revision 1/04, contained conflicting time requirements for the authentication of verbal/telephone orders (24 and 48 hours).

The policy, "Medical Record Guideline for Physicians" effective 8/25/04, only listed that it be included in the HIM (Health Information Management) manual, and did not indicate inclusion in the Medical Staff manual.

2. The policy, "Annual Performance Evaluations" last revised 12/11, states that evaluations are to be completed three months after each new employee begins work and annually on the employee's anniversary date. Four HIMD employee personnel files were reviewed on the morning of 6/12/12. One file did not contain any performance evaluations at all for the employee who was hired more than two years ago. The other three files contained performance evaluations completed in 2009. In the afternoon of 6/12/12, Personnel Manager 1 confirmed that annual evaluations had not been carried out in accordance with facility policy.

Based on medical record review and staff interview, the facility failed to ensure:
1. records of infants born in the hospital contained evidence of a signed Conditions of Admission (COA) consent in 1 of 1 record. This failure had the potential to result in the facility treating newborns without documentation of the responsible party's consent. (Patient 16).
2. licensed nursing staff and/or admissions staff completely filled out a hospital consent for surgery form for one patient in the sample (Patient 11), and all required hospital admission paperwork for two patients in the sample (Patient 8 and 25).

Findings:

1. The medical records of a mother and her newborn infant were reviewed on the morning of 6/13/12 (Patients 15 and 16, respectively). The mother's record had a signed COA consent, which contains a clause to cover the infant born in the hospital. However, a copy of this consent was not in the infant's record.

Upon interview with Admitting Lead 1 on 6/13/12 at 1:25 pm, she stated that there was no policy and procedure which outlined the process for completion and filing of COA consents.

During an interview with Health Information Manager 1 at 1:55 pm, she confirmed that it has not been the facility's practice to file a copy of the mother's signed consent in the infant's medical record. HIM1 confirmed that since the facility policy (and State regulation) is to retain newborn records for a minimum of 19 years, and adult patient records for a minimum of seven (7) years, the COA consent in the mother's record would be destroyed prior to the infant's record.



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2. During record review on 6/12/12, a "Consent to Surgery or Special Procedure" form, last approved 8/13/06, was found in Patient 11's medical records. The consent read that the procedure was for an Epidural (insertion of medication into the spinal column to cause paralysis and lack of feeling during surgical delivery of the baby) - commonly known as an Epidural for Labor and was signed on the back of the form by Patient 11.

The physician's name, the anesthetist's name, the date, the time, and the signature of the witness were missing from the consent form.

During an interview on 6/12/12 at 3:25 pm, the Director of Pharmacy (DP 1) stated the form was the hospital's consent form for surgery and that the anesthetist had her own form but that both forms should have been completely filled in. DP 1 verified the missing entries for the hospital's Epidural consent signed by Patient 11.



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3. During record review on 6/12/12, Patient 8's closed medical records was reviewed. The record did not contain documentation that all required admission paperwork had been included and/or offered to the patient by the facility. There was no documentation of the following items contained in the chart; advance directive information provided, organ donation information provided, photograph consent, smoking policy and procedures, confidentially, charity care application, conditions of admissions and patient's rights information.

During an interview and concurrent record review on 6/12/12 at 1:20 pm, the Nursing Unit Director (RND) 1 confirmed that the information was not present in Patient 8's medical record. She acknowledged that the required information should have been contained in the chart.

4. During record review on 6/13/12, Patient 25's closed medical records was reviewed. The record did not contain documentation that all required admission paperwork had been included and/or offered to the patient by the facility. There was no documentation of the following items contained in the chart; advance directive information provided, organ donation information provided, photograph consent, smoking policy and procedures, confidentially, charity care application, conditions of admissions and patient's rights information.

During an interview and concurrent record review on 6/13/12 at 3 pm, Registered Nurse (RN) 1 confirmed that the information was not present in Patient 25's medical record. She acknowledged that the required information should have been contained in the chart.

The facility's policy and procedure, titled, "Admission Policy, Acute" dated 10/2000, read, "Complete admission checklist... Review all documentation ensuring that all lines are completed and all signatures lines are signed."

Based on medical record review and staff interview, the facility failed to ensure that records contained dated and timed entries in 3 of 4 records for Patients 15, 17 and 18. This failure had the potential to result in telephone/verbal orders not being signed in accordance with facility policy and for an error in medication administration to occur if the order was misunderstood.

Findings:

Records for Patients 15, 17, and 18, reviewed on 6/13/12, contained telephone/verbal physician orders that were not dated and timed by the physicians when signed. Also, there were entries made by physicians that were not timed when written (progress notes, epidural infusion order, and medication reconcilliation order).

The facility has 2 policies: "Physician Orders--Verbal and/or Telephone" effective 2/26/07 and "Physician's Orders" last revision 1/04. These policies have different requirements regarding when acute care orders are to be authenticated (no later than 48 hours, and within 24 hours) respectively.

These findings were confirmed by Registered Nurse 2, the Director of Finance, and Health Information Manager 1 on 6/13/12 beginning at 1:55 pm.

Based on interview and record review, the facility failed to ensure patients were free from restraints, when multiple elements of the facility's restraint policy and procedure were not followed in regards to one sample patient (Patient 25). This failure put Patient 25 at risk for a negative outcome associated with the use of restraints, which could include; physical and psychological harm, loss of dignity and even death.

Findings:

The facility's "Use of Restraints or Seclusion" policy, dated 7/06, read, "Orders; Orders for behavioral restraints must be obtained from a physician. Alternatives must be considered and tried when possible before applying restraints. If the alternatives are not effective, the least restrictive restraint will be used in order from least to most restrictive... The order for restraint must include; the reason for restraint, the type of restraint and number, behavioral criteria for early removal, date and time of order and defined length of time the restraint is to be used, each written order for restraint is limited to 4-hours for adults 18 and older... When a patient is placed in restraints the following education will be provided to the patient and/or family; explanation of clinical reason for restraint, explanation for purpose and use of restraint, explanation of monitoring and care that will be provided to the patient, explanation of the criteria necessary for the termination of the restraint, any other information necessary to assure the safety and comfort, dignity, preservation of rights and well being of the patient... Plan of care; the use of restraints requires a written plan of care... Reassessment... The patient will receive an in-person reassessment by a physician to determine the efficacy of the patient's treatment pan and to identify methods to help the patient regain control. Re-Evaluation takes place at least every four hours for adults 18 and older... Documentation; each episode of restraint requires documentation in the medical records on the Restraint Record (facility form MMH250). This form contains all the pertinent aspects of restraint documentation..."

On 6/13/12, Patient 25's closed medical record was reviewed. A physician's order dated 12/30/08 at 1 am, read, "Place patient in 2 point leather restraints, if continues to be uncooperative/combative place in 4 point leather restraints." A physician's order, dated, 12/30/08 at 5 am, read, "Continue 2 point wrist restraints. Continue to assess for need per policy."

On 6/13/12 at 3 pm, Patient 25's record and the facility's restraint policy were reviewed with Registered Nurse (RN) 1 . RN 1 confirmed that she took care of Patient 25 starting at 5 am on 12/30/08. She confirmed that multiple aspects of the facility's restraint policy had not been followed in regards to Patient 25. RN 1 specifically acknowledged the following; alternatives prior to applying restraints were not documented, the physician's orders did not contain the required information specified per policy, the physician did not start with the least restrictive restraint method, the required education provided to patient's and/or their families prior to applying restraints was not clearly documented, the physician did not document the required face-to-face reassessment after 4-hours, no care plan addressing the restraints was initiated and the Restraint Record was not initiated until 12/8/08 at 5 am, despite the restraints having been applied at 1 am.