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Based on document review and staff interview, the facility failed to ensure that the Medical Staff Bylaws, Rules and Regulations complied with California Code of Regulations, Title 22, Section 70703(d) regarding the performance of the function for medical records.

Findings:

The California Code of Regulations, Title 22, Section 70703(d) states in part: "The medical staff by-laws, rules, and regulations shall include, but shall not be limited to, provision for the performance of the following functions: ...medical records .... "

On 11/18/14, the facility's Medical Staff Bylaws, Rules and Regulations, effective 3/25/14, were reviewed. There was no documentation of the medical records functions listed for the Quality Committee (QC). Earlier that day, the Director of Health Information Management had stated delinquent medical record information was reported to the QC. Also that day, Medical Staff Services Staff A stated that the QC had responsibility for medical records functions, but this had been an omission under the duties of the QC. Minutes of the QC meeting of 11/17/14 were reviewed on 11/18/14 and there was a report of delinquent medical record statistics.

Based on observation, interview, and record review, the hospital failed to effectively govern the activities and conduct of the hospital staff to provide safe, quality care to all patients as evidenced by:

1. Failure to ensure it proactively monitored the infection control program, including but not limited to the sterilization of instruments that are used hospital wide. (See A-747, A-748 and A-749)

2. The hospital's governing body did not develop a mechanism to evaluate the quality of all contracted services. (See A-084, A-283)
These failures resulted in a potential for patient harm related to non-compliant processes that had no regulatory oversight.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Governing Body.

Based on interview and document review, the hospital's governing body did not develop a mechanism to evaluate the quality of all contracted services not directly involving patient care. This had the potential to result in these services being ineffective and unsafe.

Findings:

Document review on 11/19/14 demonstrated that the "2014 Hospital Annual Evaluation of Contract Services" was limited to "patient care services provided through referral, consultation and/or contractual arrangements or agreements for patients." Each contract was evaluated according to five parameters: (a) complies with regulatory agencies, (b) complies maintaining insurance, (c) human resources requirements met, (d) complaints/occurrences or adverse outcomes regarding this service, (e) service provided information on quality improvement activities: finding reported to medical executive committee (MEC) and governing board (GB). Finally, each contract received an overall evaluation score of one to five, with one being poor service. Review of the 10/14 MEC and GB committee minutes verified that the annual evaluations were presented and approved by the committees.

Review of the entire list of hospital contracts, on 11/20/14, however, demonstrated that there was no documentation of evaluation and/or report to the MEC and the GB addressing the quality of services provided to the hospital by contractors whose services did not directly involve patient care.

Review of the hospital's 2014 performance improvement plan demonstrated that included among the performance improvement priorities were "the needs identified in operational processes" and "consideration of the entire scope of services and operations."

In interview on 11/20/14 at 10:00 a.m., the Director of Performance Improvement acknowledged that the hospital had not developed a formal protocol for evaluation of the quality of services not directly involving patient care, provided by outside contractors.

Based on inspection of 10 CADD (continuous ambulatory delivery device: used to deliver pain medication at a controlled rate) pumps being utilized by 10 patients (out of 11 patients) during the survey, review of Pharmacy V's contract with the hospital, review of a quarterly report from Pharmacy V, and interview of the Director of Pharmacy, the hospital failed to develop a quality assurance process for an activity, the compounding of sterile IV (intravenous, in the vein)solutions, identified by the Director of Pharmacy as a high risk and problem prone activity, that assured the quality (potency, identity, and sterility) of compounded IV hydromorphone (an opiate pain reliever) packaged in CADD cassettes as purchased from Pharmacy V for use by patient in the hospital. Seven patients (Patient 25, 45, 46, 47, 48, 49, and 50) were utilizing CADD cassettes from Pharmacy V during the survey. There was the potential for the product to lack sterility which could result in infection and there was potential for the potency to be more or less than stated on the label and the possibility that it may not even contain the correct medication.

Findings:

1. On 11/18/14 during an interview of the Director of Pharmacy that started at 10:48 a.m. he stated he obtained products from two compounding pharmacies, Pharmacy V and Pharmacy W. He stated he only obtained a few items from Pharmacy V as Pharmacy W did batch testing of all of their items (which Pharmacy V did not).

On 11/20/14 at 2:06 pm the surveyor asked the Director of Pharmacy to show the surveyor what Pharmacy V stock he had on hand. The Director of Pharmacy produced 4 CADD pump cassettes, from the controlled drug (drugs subject to abuse) supply stored in the pharmacy that had been filled by Pharmacy V and labeled as containing hydromorphone 1mg/ml (milligram/milliliter) with an expiration date of 12/6/14.

On 11/21/14 a review of a list of patients receiving hydromorphone via CADD devices indicated that there were 11 such patients in the hospital. An inspection of 10 out of the 11 patients' pumps on that date between 5:15 pm and 6:20 pm on that date indicated that 7 patients had CADD pumps utilizing a cassette produced by Pharmacy V while 3 had cassettes from Pharmacy W.

On 11/20/14 at 3:17 pm a review of Pharmacy V's contract with the hospital indicated it contained the following language: "The center will be operated consistent with applicable Federal and State license requirements and regulations established for such service. The Center will operate in accordance with applicable Good Manufacturing Practices .... "

On 11/20/14 at 5:30 pm during an interview of the Director of Pharmacy the surveyor asked him how Pharmacy V was meeting this contractual obligation and he stated he looked at quarterly reports provided by Pharmacy V. When asked by the surveyor, the Director of Pharmacy provided a copy of Pharmacy V's Quarter 3, 2014 quality report.

On 11/20/14, a review of this report indicated it documented indicators (such as non-viable and viable particle counts: non-viable particle counts are a measure of particulate burden in a defined volume of air while viable particle counts measure colonies of bacteria from particles in the air and is a measure of the potential to contaminate sterile products) that it monitored regarding the physical environment of the compounding facilities owned by Pharmacy V. It provided bar graphs for complaint rates per 1 million units produced, but the nature of the units produced was not documented. It provided data on internal related service issues which documented shipment issues regarding Pharmacy V products. It documented delivery related issues with regard to Pharmacy V products. It documented there were no media positives, sterility positives, or stability issues as being out of limits in the third quarter at all Pharmacy V compounding centers out of approximately 240 tests a month but it did not document the actual products tested. It provided hood sampling data for viable particle counts for both the surface of the hoods as well as the hood air. There was no specific medication related data as to sterility of the product or the final potency and identity of the finished product.

During an interview on 11/20/14 at 5:30 pm, regarding the provided quarterly report, the Director of Pharmacy stated he did not know what the numbers provided on the hood sampling data meant. He stated that the data provided on three graphs regarding media positives, sterility positives, or stability issues as being out of limits told him nothing about the Pharmacy V product he had in stock. He stated that this report told him "nothing" really about the potency, identity, and sterility of the CADD hydromorphone cassettes he had purchased from Pharmacy V. He stated that he had no quality assurance data that ensured the potency, identity, and sterility of the hydromorphone cassettes to the expiration date printed on the cassette label. He also stated that he felt that IV compounding is a problem prone area and could be a high risk activity.

Based on observation, interview and record review, the nursing staff who cared for one of 44 sampled patients failed to ensure supervisory personnel (Nurse Director, ND A) was informed of a change in a patient's condition when Patient 9 had developed skin complications which included: open wounds, dark red and purple toes and heel.
This failed practice had the potential for the needs of the patient to be unmet.

Findings:

1. On 11/20/14 at 2 pm, Patient 9's record was reviewed concurrently with ND A. Patient 9 was admitted to the hospital on 11/4/13, with diagnoses which included blood infection, kidney and liver failure. The record indicated when Patient 9 was admitted on 11/4/14, Patient 9 did not have any skin issues and skin was intact.

Patient 9's daily Care Activity Assessments (CAA, nurses progress notes) indicated the following:
On 11/9/14 at 7 am, Patient 9 had two small blisters on her left shin, no broken skin.
On 11/11/14 at 8 am, the blisters had opened on the shin area, and were covered with a dressing.
On 11/17/14 at 7:26 am, under wound assessment, left shin reddened, draining and swollen.
On 11/18/14 at 7:25 pm, open blisters to shin, bright red. Left heel dark purple bruise swollen, darkened purple areas between 4th and 5th toes. Will continue to monitor and initiate wound care consultant.

On 11/19/14 at 2:11 pm, Wound Care Consultant (WCC A) documented Patient 9 had the following:
Left lower extremity draining partial thickness (involved layers of skin) wound 16 centimeters (cm) by 6 cm;
Fourth and fifth toes purple swollen, and the left heel was dark. "She has partial thickness skin loss from blistering that has opened up. ... looks to have vascular changes from decreased blood flow. She has dark blister to the shin, dorsal of her foot and the 4th and 5th toes are involved too. I explained the physician needed to be shown the leg today. Studies have been done."

On 11/20/14 at 2:20 pm, ND A confirmed the above findings, and stated she had not been made aware of the change in Patient 9's condition until 11/18/14, when the nurse informed her of the plan to refer Patient 9 to the WWC A. ND A stated when a Nurse Manager is informed of a patient's condition change it allows the Nurse Manger to assist the staff nurse in caring for the patient and potentially improve patient outcomes. ND A stated she should have been informed by 11/11/14, when Patient 9's blisters opened up and became wounds.

The hospital's job description for the Registered Nurse included, "reports to Director."

Based on observation, interview, record review, the hospital's policy was not followed when;
1. One of 44 sampled patients (Patient 9) developed skin complications and the record did not show evidence of wound measurements or photographs of new wounds.
2. Three of 27 patients (Patients 2, 3 and 4) on the medical/surgical floor were observed to have peripheral intravenous dressings that were not dated.
3. Two of 44 sampled patients (Patients 12 and 13) did not have pain assessments conducted as per hospital standard and have pain treated as per the physician's order.

These failed practices had the potential for patients not to receive appropriate care, develop complications, and compromise their health when hospital policies were not followed.

Findings:

1. On 11/20/14 at 2 pm, Patient 9's record was reviewed concurrently with Nurse Director (ND A). Patient 9 was admitted to the hospital on 11/4/13, with diagnoses which included blood infection, kidney and liver failure. The nurses notes indicated on 11/11/14 at 8 am, Patient 9 had blisters that had opened on the shin area, and were covered with a dressing.
On 11/17/14 at 7:26 am, under wound assessment, left shin reddened, draining and swollen.
On 11/18/14 at 7:25 pm, open blisters to shin, bright red. Left heel dark purple bruise swollen, darkened purple areas between 4th and 5th toes. Will continue to monitor and initiate wound care consultant.

On 11/19/14 at 2:11 pm, the Wound Care Consultant (WCC) documented Patient 9 had the following:
Left lower extremity draining partial thickness (involved layers of skin) wound 16 centimeters (cm) by 6 cm;
Forth and fifth toes purple swollen,
and the left heel was dark. "She has partial thickness skin loss from blistering that has opened up. ... looks to have vascular changes from decreased blood flow. She has dark blister to the shin, dorsal of her foot and the 4th and 5th toes are involved too. I explained the physician needed to be shown the leg today. Studies have been done."

The record did not contain evidence of wound measurements or wound photographs until 11/19/14, eight days after Patient 9 had developed open wounds.

A policy dated 2/2014, titled, Skin Integrity, instructed to document wound assessment including location and size. Photographs should be included in the medical record to support documentation. Wounds will be photographed with change in condition, upon discovery of a new wound, weekly.

On 11/20/14 at 4:20 pm ND A confirmed the above findings, and stated Patient 9's wounds were not measured or photographed as instructed per policy.



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2. During the initial tour of the medical surgical unit on the third floor on 11/18/14 starting at 11 am with the Director of Performance Improvement (DPI), three of 27 patients were observed to have peripheral intravenous (PIV) dressings with no labels to show when they were initiated (Patients 2, 3, and 4).

The DPI confirmed the observations and stated that the PIV dressings needed to include labels and when they were dated when they were initiated per hospital policy.

A review of the hospital's policy titled, "Peripheral IV Insertion, Administration, Maintenance and Discontinuation," dated 9/2013, indicated that all PIV sites shall be labeled with the date and time of insertion, and the initials of the nurse inserting the PIV catheter. This information is to be written on the exterior semi-transparent dressing.



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3. Patient 12 was admitted to the facility on 11/15/14 with diagnosis which included heart disease, alcohol abuse, congestive heart failure (too much fluid in the lungs because the heart does not pump well), and Diabetes.

A record review conducted on 11/19/14 at 8:30 am indicated that on 11/18/14, 12 was discharged to home. Patient 12's record further indicated that he had received Morphine Sulfate (a strong narcotic pain medication) 2 milligrams (mg) intravenous (IV-through the vein) at 7:36 am, for a pain level of 8 (severe), on the day of discharge. The record further indicated that the pain was reassessed at 11 am and the pain level was 6. Patient 12 was discharged on 11/18/14 at 4:19 pm without another vital sign assessment or pain scale assessment (a five hour lapse after the last vital sign/pain assessment). Patient 12 did not receive Morphine as ordered for a pain level of 6 at 11 am and there was no documentation to indicate why further pain relief was not given.

A review of Patient 12's physician orders, dated 11/15/14, timed 10:35, indicated that Morphine 2 mg IV was ordered to be given every 4 hours for severe pain (pain scale level 7-10) and Morphine 1 mg IV was ordered to be given every 4 hours for a pain scale level of moderate pain (pain scale level of 4-6).

A record review of Patient 12's initial assessment, dated 11/15/14, timed 11:52 pm, indicated that he had back pain with a pain score of 6. Further review of this pain assessment indicated that the pain management goal section was not completed. This section would provide information to the care provider of what the usual or acceptable level of pain relief would be as indicated by Patient 12.

During an interview conducted on 9/19/14 at 9:30 am, Nurse Director (ND) A stated that every patient should have a pain assessment done with vital signs, that pain should be reassessed within two hours after the administration of pain medication, a pain management goal should have been identified on the pintail assessment to ensure proper pain management, and that vital signs should be reassessed at the time of discharge. ND A validated that these elements of patient assessment should have been completed and were not.

4. Patient 13 was admitted to the facility on 11/16/14 with diagnosis which included a rapid heart rate, congestive heart failure, high blood pressure, and chronic pain.

A record review of vital signs assessments for Patient 13, conducted on 11/19/14 at 9:35 am, indicated that Patient 13 did not have documented pain assessments conducted with vital signs for the date of 11/18/14 between the hours of 6 am till 10 pm, a time frame greater than 12 hours.

During an interview conducted on 11/19/14 at 9:50 am, ND A confirmed that pain assessments should have been documented and were not.

Based on observation, interview and record review, the hospital failed to ensure the nursing care plan (NCP, process plan) was developed and was current for three of 44 sampled patients when:
1. The care plan for Patient 9 did not reflect that Patient 9 had developed blisters on her leg which became open skin wounds and two of her toes and heel had became dark red and purple.
2. Care plans for pain management were not developed or implemented for Patients 12 and 13.

This failed practice had the potential for the nursing care needs of patients to be unmet and compromise health outcomes.

Findings:

1. On 11/20/14 at 2 pm, Patient 9's record was reviewed concurrently with Nurse Director (ND A). Patient 9 was admitted to the hospital on 11/4/13, with diagnoses which included blood infection, kidney and liver failure. The record indicated on 11/4/14, Patient 9's left leg and foot did not have any skin issues and skin was intact.

Patient 9's daily Care Activity Assessments (CAA, a nurses progress notes) indicated on 11/9/14 at 0700, Patient 9 had two small blisters on her left shin, no broken skin, and on 11/11/14 at 8 am, the blisters were open on the shin area, and were covered with a dressing.

On 11/18/14 at 7:25 pm, the CAA indicated Patient 9 had open bright red blisters to shin, the left heel was dark purple bruised and swollen, and between the between 4th and 5th toes was dark purple. "Will continue to monitor and initiate wound care consultant."

The NCP was reviewed concurrently with ND A and WCC B. The record did not show evidence the NCP had been updated on 11/9/14, when Patient 9 had first developed left lower extremity skin issues which included blisters, or was revised as the blisters had become open wounds, and developed dark purple skin between the 4th and 5th toes and the left heel.

The record indicated the NCP was updated after WCC B had visited Patient 9 on 11/19/14. New information was then added to the NCP to include Patient 9's skin issues.

On 11/20/14 at 4:20 pm the WWC B and ND A confirmed the above findings, and stated the NCP should have been updated to include skin issues on 11/9/14, when Patient 9 first developed blisters on her left leg, and updated as Patient 9's blisters worsened, and her toes and heel became dark.

A policy dated 2/2014, titled, Skin Integrity, instructed to initiate a Care Plan for patients at risk for or with open or pressure wounds.

The facility's policy, dated 10/13, titled, "Process Plan (Plan of Care)" instructed, "The Process Plan shall be an interdisciplinary tool based based on data gathered during the patient assessment and is updated on a continuing basis during the hospital stay. Each care plan in the Process Plan will be individualized per the patients identified problems. Evaluate the Process Plan at least every 12 hours. Initiate/revise the Process Plan to include the identification of problems, measurable outcomes and interventions."



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2. Patient 12 was admitted to the facility on 11/15/14 with diagnosis which included heart disease, alcohol abuse, congestive heart failure (too much fluid in the lungs because the heart does not pump well), and Diabetes.

Patient 12's initial assessment, dated 11/15/14 at 11:52 pm, indicated that he had back pain with a pain score of 6. Further review of this pain assessment indicated that the pain management goal section was not completed. This section would provide information to the care provider of what the usual or acceptable level of pain relief would be as indicated by Patient 12. A review of Patient 12's record showed there was no plan of care for pain.

During an interview on 9/19/14 at 9:30 am, ND A stated that a plan of care should have been developed for pain management for Patient 12 and was not.

3. Patient 13 was admitted to the facility on 11/16/14 with diagnosis which included a rapid heart rate, congestive heart failure, high blood pressure, and chronic pain. A record review conducted on 11/19/14 at 9:30 am, indicated that Patient 13 did not have a plan of care developed for pain.

During an interview conducted on 11/19/14 at 9:50 am, ND A confirmed that a plan of care addressing pain should have been developed for Patient 13 and was not.

Based on interview and record review, the hospital failed to ensure that specialized care was provided for one of 44 sampled patients (Patient 9) when she developed skin complications.

This failed practice resulted in a delayed referral to a Wound Care Consultant (WWC) and a decline in Patient 9's wounds. This practice had the potential for patient's to develop complications and compromise health outcomes.

Findings:

On 11/20/14 at 2 pm, Patient 9's record was reviewed concurrently with Nurse Director (ND A). Patient 9 was admitted to the hospital on 11/4/13, with diagnoses which included blood infection, kidney and liver failure. The nurses notes indicated on 11/11/14 at 8 am, Patient 9 had blisters that had opened on the shin area, and were covered with a dressing.
On 11/17/14 at 7:26 am, under wound assessment, left shin reddened, draining and swollen.
On 11/18/14 at 7:25 pm, open blisters to shin, bright red. Left heel dark purple bruise swollen, darkened purple areas between 4th and 5th toes. Will continue to monitor and initiate wound care consultant.

The record did not contain evidence of a referral to a WCC until 11/19/14, eight days after Patient 9 had developed open wounds.

On 11/19/14 at 2:11 pm, Wound Care Consultant (WCC B) documented Patient 9 had the following:
Left lower extremity draining partial thickness (involved layers of skin) wound 16 centimeters (cm) by 6 cm;
Forth and fifth toes purple swollen,
and the left heel was dark. "She has partial thickness skin loss from blistering that has opened up. ... looks to have vascular changes from decreased blood flow. She has dark blister to the shin, dorsal of her foot and the 4th and 5th toes are involved too. I explained the physician needed to be shown the leg today. Studies have been done."

On 11/20/14 at 4:20 pm ND A confirmed the above findings, and stated the policy for Skin Integrity did not instruct the nurse when to make a referral to the WWC for a patient with a non-pressure open wound. ND A stated Patient 9 should have been referred to the WCC on 11/11/14, when Patient 9's left shin blisters became open wounds.

A policy dated 2/2014, titled, Skin Integrity, instructed the nurse to refer to the WCC for pressure related wounds. The policy did not direct when the nurse should refer a patient to the WCC for a non-pressure wound(s).

On 11/21/14 at 10 am, the Director of Performance Improvement stated the hospital's policy for Skin Integrity focused on pressure related wounds and ulcers, and needed to be revised to include guidelines/instructions when the nurse should refer a patient to the Wound Care Consultant to evaluate a wound which was non-pressure related.

Based on observation and record review of three nurses passing medications to three patients (Patients 21, 22, and 23) on the 11/19/14 morning shift on the Medical Surgical Floor, one nurse made one error out of a total of 17 opportunities for error among the three patients. Nurse Q administered 86 mg (milligrams) of Solumedrol (a glucocorticoid used to treat inflammation) instead of 80 mg as ordered by the physician.

Findings:

On 11/19/14 at 8:43 a.m. Nurse Q administered 1.38 ml (milliliters) of Solumedrol to Patient 23 via her IV line followed by a flush of the line using normal saline (0.9% sodium chloride for injection). The Solumedrol vial label from which Nurse Q withdrew this dose documented it contained 125 mg of Solumedrol for each 2 ml (or 62.5 mg/ml) hence she gave 86 mg of Solumedrol to Patient 23.

On 11/19/14 a review of Patient 23's electronic medical record indicated a physician had prescribed an 80 mg dose of methylprednisolone (Solumedrol) every 8 hours by the IV route, not an 86 mg dose.

Based on staff interview, the facility failed to ensure that there were written policies and procedures to ensure prompt retrieval of records from the off-site location. This failure had the potential to result in medical records not being readily available in the event that staff were not aware of the process to request records from off-site.

Findings:

During an interview, with the Director of Health Information Management, on the morning of 11/18/14, she stated that medical records were stored in an off-site warehouse. This surveyor asked to review the policy and procedure (P&P), that addressed how records were retrieved and she stated, on the afternoon of 11/19/14, that there was no such written P&P.

Based on document, medical record reviews, and staff interview, the hospital failed to ensure that medical record entries were accurately written and promptly completed in three of seven closed records reviewed.

Findings:

The following medical records were reviewed on the morning of 11/21/14 with the assistance of Health Information Management Tech A, who confirmed these findings concurrently:

1. In Record 35, a Registered Nurse documented on the Expiration Memorandum form: "Pronounced Time of Death: 0810." At the bottom of the page were preprinted spaces for "Signature____ Date:_____ Time:______ " which were blank. In the Discharge/Death Summary (dictated by the physician and transcribed), it contained the statement, "The patient expired ...at 1010 hours." HIM Tech A explained that 1010 was the time the patient was officially discharged.

2. In Record 41, the Conditions of Admission consent was signed by the mother of the patient. There was a preprinted space on the consent form to document the reason the patient was unable to sign, and this was blank.

3. In Record 31, the section of the Conditions of Admission consent regarding organ donation was blank. The form had a preprinted "___Yes ___No" field which was to be completed.

Based on document review and staff interview, the facility failed to ensure that all medical record entries were complete and legible when there was no reference available to determine the approved meaning of abbreviations. Also, the medical staff security statement for the use of electronic signatures was not comprehensive for all the providers allowed to electronically sign entries. These failures had the potential to result in abbreviations being misinterpreted, since there may often be more than one meaning for an abbreviation, and to potentially result in medical record entries being electronically signed by a person other than the individual whose signature it represents.

Findings:
1. The Administrative policy, "Abbreviations, Use of," revised 11/2013 was reviewed on the morning of 11/19/14. It stated in part: "Approved abbreviations can be found in Stedman's list of abbreviations." On the afternoon of 11/18/14, the Director of Health Information Management was asked for a copy of this reference. On the afternoon of 11/19/14, she said there was no hard copy, but it could be accessed on-line. However, the next day when she was asked to look-up some abbreviations that were used in medical records, she was unable to access this on-line reference, because apparently a subscription was required.

2. The Medical Staff Security/Confidentiality Agreement was reviewed on the afternoon of 11/18/14. During an interview with the Director of Performance Improvement in the late morning of 11/21/14, she stated the form also applied to the Allied Health Providers; however, this group was not specifically mentioned on the form. Additionally, the form only described "remote system access" as the situation for which unauthorized access or disclosure of the physician's unique identifier applies but not access in other areas, such as within the hospital.

Based on inspection of the labels on six compounded IV (intravenous) solutions in the Pharmacy IV room, review of Patient 21's EMR (electronic medical record), inspection of one out of three Adult Crash Carts (contains medication and equipment used to manage medical emergencies) in the ED (Emergency Department), the RSI Kit (rapid sequence intubation kit: contains medication used to facilitate the placement of an air tube in patients who cannot breathe on their own) placed in the ED Adult Crash Cart, inspection of one out of one Pediatric Crash Carts in the ED, inspection of one out of two MH (malignant hyperthermia: a potentially lethal side effect of certain medications used in anesthesia) Carts in the Surgery Department, review of a crash cart checklist found on top of the ED Adult Crash Cart, review of hospital policies, and staff interview:

1. The hospital failed to ensure staff filled in the time a compounded IV solution was made in the space on the IV label provided for that purpose to ensure the IV was not stored or transported after that time (the beyond use date or BUD) as required by the standard the Director of Pharmacy and hospital policy indicated the hospital followed for compounding IV solutions: Chapter 797 of the United States Pharmacopeia (USP 797: a chapter that establishes standards for compounding sterile products and which is enforceable by the Food and Drug Administration and, therefore, a standard of practice). As result IVs could be used after the beyond use date established by USP 797 (see #1).

2. The hospital failed to ensure that the hospital policy for compounding IV solutions and a checklist contained in that policy (to be used by staff in monitoring the IV compounding process) provided for the removal and replacement of a sterile IV bag of water attached by an IV transfer line to a pump syringe (used to reconstitute powdered drugs in vials during a compounding process) after six hours as required by USP 797 (when placed inside the clean environment of a compounding IV hood) instead of after 8 hours as documented on the checklist or 24 hours as documented in the policy itself. As a result, the sterile water could be used longer than indicated in USP 797 which could result in contaminated IV solutions (see #2).

3. The hospital failed to ensure that a pharmacist correctly made a hospital policy approved therapeutic substitution (a substitution of one drug for another drug with the same therapeutic effect) of famotidine (reduces stomach acid) for ranitidine (reduces stomach acid) for Patient 23 as stipulated by the approved hospital policy for therapeutic substation. The pharmacist substituted a 20 mg (milligram) dose of famotidine for a 300 mg dose of ranitidine instead of a 40 mg dose of famotidine as stipulated by the policy. As a result, Patient 23 received less than the hospital determined dose of famotidine which may have resulted in a less than intended outcome (see #3).

4. The hospital failed to ensure that a pharmacist clarified a medication order conflict with a physician as required by hospital policy, which was generated by the decision support tools in the hospital computerized medication physician order entry system and computerized pharmacy medication profile system when the physician entered a second medication for the same indication for the treatment of severe pain, in Patient 21's medication regimen. As a result Patient 21 had an order for hydrocodone/acetaminophen for severe pain and oxycodone/acetaminophen for moderate to severe pain which would require the nurse to choose between two medications in the same class, Schedule II opiate based pain relievers, for the same indication (severe pain) without clear direction from the order set as to how to do this. Hydrocodone and oxycodone are opiate pain relieving medications classified as Schedule II medications (medications with a high potential for abuse) in the Uniform Controlled Substance Act of 1970 even when combined with acetaminophen (the active pain relieving medication found in Tylenol ®: see #4).

5. The hospital failed to ensure that one out of three Adult Crash Carts in the ED, the RSI Kit contained in that crash cart, one out of one Pediatric Crash Carts in the ED and one out of two MH Carts in the Surgery Department were stocked according to Hospital Policy established lists for the crash cart, RSI Kit, and Pediatric Crash Cart and the hospital approved content list for the MH Cart. The Adult Crash Cart contained four instead of eight epinephrine (used to promote return of spontaneous circulation in patients whose hearts are not pumping effectively) PFSs (pre-filled syringes) and one 10 ml (milliliter) vial of flumazenil (used as an antidote to treat overdoses due to benzodiazepines such midazolam [used as sedatives]) instead of two 5 ml vials. The RSI Kit in this Adult Crash Cart contained one 20 ml vial of etomidate (used to induce anesthesia) instead of two 10 ml vials. The Pediatric Crash Cart contained one 5 ml vial of dopamine (used to maintain blood pressure) 40 mg/ml instead of one 5 ml vial of dopamine 80 mg/ml. The MH Cart contained two bottles of povidone/iodine (a disinfectant) scrub (7.5 % povidone/iodine) instead of two bottles of povidone/iodine solution (10% povidone/iodine). Failure to stock these supplies as indicated could result in errors or lack of availability of a medication during a medical emergency and in the case of the povidone/iodine, the use of a lesser concentration of the active ingredient used to disinfect skin prior to placing an IV line (see #5).

6. The hospital failed to ensure staff checked the ED refrigerator for the presence of succinylcholine from 11/1/14 through 11/21/14 (the day of the survey observation) as stipulated in a hospital policy and procedure as no one had checked this off on the check list found on top of the chart. Failure to check for the presence of this medication, used to facilitate the placement of an air tube in patients unable to breathe on their own, could result in its unavailability during a medical emergency (see #6).

Findings:

1. The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines ...USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP 35/NF 30). The USP revised general chapter <797> (USP 797) entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death to patients that could result from microbial contamination and excessive bacterial toxins among other things." If a hospital puts all the environmental controls as well as all the personnel training, certification, and compounding practices into place as described in USP 797, the hospital can assign beyond use dates (BUDs: date or time beyond which an IV product cannot be stored or transported) to compounded IV products as described in USP 797.

USP 797 provides for three risk levels of contamination when compounding compounded sterile products (CSPs): low, medium, and high. USP 797 defines low risk CSPs are those that involve "...only the transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or package." Medium risk compounding is more complex than low risk, while high risk compounding involves the compounding CSPs starting with non-sterile products that are sterilized during the compounding process. In the absence of passing a sterility test, USP 797 documents that low risk CSPs can be assigned a BUD of 48 hours when stored at controlled room temperature (68 to 77 degrees F) and medium risk CSPs can be assigned a BUD of 30 hours when stored at controlled room temperature.

On 11/18/14 during an interview with the Director of Pharmacy that started at 10:48 am he stated his pharmacy department followed USP 797 standards when compounding IV solutions in his pharmacy and that only low and medium risk IVs were compounded in the hospital.

On 11/19/14 during an inspection of the pharmacy IV room starting at 3:51 p.m. the surveyor noted the following:

a. Two 1000 ml IV bags labeled as 850 ml of 5% dextrose in water (D5W: used as fluid replacement as well as carrier solution for other medications) with 150 mEq (milliequivalents) of sodium bicarbonate (used to lower acid levels in blood and available as 50 ml vials so a total of 150 ml was added to the bag) for a total volume of 1000ml. The bags were labeled as due at 12:50 am and 10:50 am on 11/20/14. The label provided a space for the date and time of the BUD but only the date "11/20/14" was filled in by staff.

b. Two 1000 ml IV bags labeled as 850 ml of D5W with 150 mEq of sodium bicarbonate for a total volume of 1000ml. The bags were labeled as due at 9:25 pm on 11/19/14 and 7:25 am on 11/20/14. The label provided a space for the date and time of the BUD but only the date "11/20/14" was filled in by staff.

c. Two 1000 ml IV bags labeled as 900 ml of D5W with 100 mEq of sodium bicarbonate (two 50 ml vials so a total of 100 ml added to the bag) for a total volume of 1000ml. The bags were labeled as due at 8:30 pm on 11/19/14 and 6:30 am on 11/20/14. The label provided a space for the date and time of the BUD but only the date "11/19/14" was filled in by staff on the first bag and "11/20/14" on the second bag.

During an interview with the Director of Pharmacy at that time he stated that staff withdrew between 100 and 150 ml of D5W from the IV bag purchased from a manufacturer and added the between 100 ml to 150 ml of sodium bicarbonate. He stated the largest syringe available for use in the pharmacy was a 60 ml syringe so a bag would be punctured twice to remove 100 ml and punctured three times to remove 150 ml of solution. Therefore the IV bag was punctured between four to six times to complete the compounding process (two to three times to remove the required amount of D5W and two to three times to add the required amount of sodium bicarbonate). The Director of Pharmacy stated that IV solutions were normally not reused but if they were reused they would be "logged in". The Director of Pharmacy stated that there were two IV shifts each day. He said the morning shift made IVs that were due between Noon and 8 pm and the afternoon IV shift made the IVs that were due from 8 pm to Noon the next day. He stated the IVs were made in the afternoon between 1 to 1:30 pm to 3 pm.

During an interview with Pharmacy Technician (PT) R at 4:07 pm on 11/19/14, she stated that today's afternoon run had ended at 3:30 pm (therefore the latest BUD would be at 9:30 pm the following day for medium risk IVs). She also stated that the IV could "get behind" (be hung by nursing staff on a patient later than the time assigned on the label) due to patient procedures or blood being given to a patient. She pointed out that the IV of 900 ml D5W with 100 mEq of sodium bicarbonate (see "c." above) that was labeled as due 8:30 pm on that night (of 11/19/14) had been made yesterday and had been reused. PT R stated she had made the IV between 2 to 2:30 pm yesterday (11/18/14).

Based on PT R's testimony, this last IV would have a BUD of 8 to 8:30 pm that night (11/19/14) which was just prior to or just at the time the bag was due to be hung by staff. If something happened that delayed the hanging of the bag as described above by PT R, the bag would be hung after the BUD.

The above observations were verified by the Director of Pharmacy by interview at that time and date.

On 11/20/14 at 9:16 am a review of Policy and Procedure 4.4.01 entitled IV ADMIXTURE SERVICES (Approved 11/11, Revised 10/12) indicated that it defined low and medium risk CSPs and the definition was in line with USP 797 definitions. "References" included at the end of the policy included "USP 797 Requirements for IV room Compounding 2008". During an interview of the Director of Pharmacy at 10:41 am on 11/20/14, he stated he used USP 797 to formulate the IV policy. He stated that USP 797 was the standard the hospital followed to compound CSPs unless a stricter standard existed, then the stricter standard would be followed.

2. USP 797 defines a "Single-Dose Container" as " ...a single-unit container for articles or preparations intended for parenteral administration only. It is intended for single use ... " Under "SINGLE-DOSE AND MULTIPLE-DOSE CONTAINERS" it indicated: "Opened or needle-punctures single dose containers, such as bags, bottles, and vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5 (3,500 particles [of 0.5 micrometers or greater] or less per cubic meter and which is produced by filtering air through a high efficiency particulate air filter to remove most contaminants: a very high standard for clean air usually produced within IV compounding hoods or cabinets) or cleaner air ...Single dose vials exposed to ISO class 5 or cleaner air may be used up to 6 hours after initial needle puncture."

On 11/20/14 at 9:16 a.m. a review of Policy and Procedure 4.4.01 entitled IV ADMIXTURE SERVICES (Approved 11/11, Revised 10/12) indicated that it included an "IV Room Checklist" (Updated 1/27/2013) at the back of the policy and column one of this checklist was entitled "Water change (Q8H)". The phrase Q8H means every eight hours. There were 31 rows corresponding to 31 days in a month. Furthermore, page 19 of 20 documented under "IV room Checklist Process: that "Water Change" referred "...to the Sterile Water that is aseptically placed underneath the hood for use throughout the day. This must be changed at least every 24 hours ..."

On 11/20/14 at 10:43 am during an interview with the Director of Pharmacy he stated this column heading referred to an IV bag of sterile water for injection (no preservatives) hung in the IV hood to which pharmacy compounding staff attached a pumping syringe attached to the IV bag via an IV transfer line. It was used to reconstitute powdered drugs in vials before adding them to an IV bag (which would subsequently be sent to the floor to be administered to a patient). The Director of Pharmacy said he could not give a reason why he should not follow the USP 797 limit of 6 hours for single use vials punctured in an ISO Class 5 environment in assigning the change time for the IV bag of sterile water hung in the hood for reconstituting powdered medications. The Director of Pharmacy stated that the language found on page 19 of 20 regarding changing the sterile water every 24 hours was not in agreement with USP 797.

3. On 11/19/14 at 9:30 am a review of Patient 23's EMR (electronic medical record) indicated that a physician ordered Ranitidine 300 mg once a day for Patient 23 by selecting the "continue" option of the Home Med reconciliation sheet created by staff when a patient was admitted to the hospital. At 8:08 pm on 11/17/14, a pharmacist changed the order to famotidine 20 mg daily. During a concurrent interview, the Director of Pharmacy verified this observation and stated that this was allowed per a therapeutic substitution policy.

On 11/19/14 a review of Policy and Procedure H29 entitled HOSPITAL FORMULARY (Formulated 6/05, Revised 10/14) indicated that it provided for therapeutic substitution of one drug for a "therapeutically equivalent" drug as provided for by a hospital approved substitution list. A review of the attached list indicated that a 40 mg dose (not a 20 mg dose) of famotidine could be substituted for a 300 mg dose of Ranitidine.

During an interview with the Director of Pharmacy on 11/19/14 at 10:43 am, he verified what was in the hospital policy and stated that the pharmacist failed to make the substitution correctly.

4. On 11/19/14 a review of Patient 21's EMR indicated that it contained the following orders:

a. Hydrocodone/acetaminophen 10 mg/325 mg one tablet orally every four hours as needed for severe pain (ordered 11/17/14 at 5:40 pm).

b. Oxycodone/acetaminophen 5 mg/325 mg two tablets orally every six hours as needed for moderate or severe pain (ordered 11/19/14 at 9:05 am).

A review of the order detail provided by the Director of Pharmacy at that time indicated that the order documented "Duplicates at Order Entry" as a "conflict" and that the pharmacist who approved the order entered "NO CLINICAL SIGNIFICANCE" after "Duplicate Comment".

On 11/19/14 at 11:44 am during an interview with the Director of Pharmacy, he stated that it was incorrect to document that having both these orders active for the same indication (severe pain) was of "no clinical significance". He stated that the hospital had a policy regarding this and provided Policy and Procedure H49.

On 11/19/14 at 11:49 a.m. a review of Policy and Procedure H49 entitled MEDICATION DISPENSING (Formulated 12/95, Revised 7/14) indicated it documented: "Upon receipt of an order ...The pharmacist will review all orders for the following: Any therapeutic duplications". It also documented: "All concerns, issues, or questions regarding a medication order will need clarification prior to the dispensing of the medication." During a concurrent interview with the Director of Pharmacy, he stated that Patient 21's orders had not been clarified as otherwise his staff would have discontinued one of the orders or would have entered a note that the physician wanted both orders. He stated that the policy had not been carried out as written as the EMR documented an order conflict and the conflict had not been addressed correctly.

5. On 11/21/14 an inspection of emergency medication supplies in the ED and in the Surgery Department revealed the following issues:


a. On 11/21/14 at 9:31 am an inspection of one out of three Adult Crash Carts in the ED indicated it contained four 10 ml PFSs of epinephrine 1 mg/10 ml (1:10,000) and one 10 ml vial of flumazenil 0.1 mg/ml. The approved content list on the outside of the cart indicated it should contain eight such epinephrine PFSs and two 5 ml vials of flumazenil 0.1 mg/ml.

b. On 11/21/14 at 9:31 am an inspection of one out of three Adult Crash Carts in the ED indicated it contained a sealed RSI Kit. Inspection of that kit indicated it contained one 20 ml vial of etomidate 2 mg/ml. The approved content list on the outside of the cart indicated it was to contain two 10 ml vials of etomidate 2 mg/ml.

c. On 11/21/14 at 10:53 am an inspection of one out of one Pediatric Crash Carts located in the ED indicated it contained one 5 ml vial of dopamine 40 mg/ml. The approved content list on the outside of the cart indicated that it contained one 5 ml vial of dopamine 80 mg/ml.

d. On 11/21/14 at 11:22 am an inspection of the one out of two MH Carts located in the Surgery Department (the inspected cart was located in the Post Anesthesia Care Unit while the second was located in the area where the operating rooms were located) indicated it contained two bottles of povidone/iodine scrub labeled to contain 7.5% povidone/iodine. The approved content list located outside of the cart documented it contained two bottles of povidone/iodine solution. At 11:53 am an inspection of the pharmacy indicated it stocked both the povidone/iodine scrub and the solution. The bottle of povidone/iodine solution documented it was a 10% solution of povidone/iodine as opposed to 7.5% for the scrub.

The above observations were verified by the Director of Pharmacy.

On 11/21/14 a review of Policy and Procedure A04 entitled CRASH CART CONTENTS & CHECKLIST (Formulated 6/02, Revised 11/12) indicated that the documented content of the cart included the epinephrine, flumazenil, and (in the RSI Kit) etomidate as documented on the externally posted content lists observed on the outside the ED Adult Crash Cart. On 11/21/14 a review of the approved MH Cart content list indicated it was to contain two bottles of povidone/iodine solution, not scrub.

6. On 11/21/14 at 9:31 am during an inspection of one out of three Adult Crash Carts in the ED, a review of the Crash Cart Checklist dated for November 2014 posted outside of this crash cart indicated it provided a space for each day of the month for staff to check off that they had checked the availability of succinylcholine in the refrigerator. Staff had not checked this off for any of the days of November from the first of the month through the 21st (the day of the survey observation) hence there was no evidence that staff had actually checked the refrigerator for the presence of the succinylcholine. The Director of Pharmacy verified this observation at that time during an interview.

On 11/21/14 a review of Policy and Procedure A04 entitled CRASH CART CONTENTS & CHECKLIST (Formulated 6/02, Revised 11/12) indicated that staff was to place the current month's checklist on a clipboard on top of the crash cart. It documented that the RSI Kit was stored in the crash cart in drawer 5 with the exception of succinylcholine which was stored in the refrigerator. Under "Crash Cart Checklist Procedure" it documented at #5: "Indicate the presence of items listed on the checklist by placing a check mark next to the item listed on the form."

Based on observation of a sealable plastic bag containing labeled vials of home medications (for Patient 24) lying on a table within three feet of the entrance to Room 5 in the ED (Emergency Department), review of policies and procedures, and staff interview, the hospital failed to develop a procedure to ensure that home medications brought to the ED by Patient 24 (and potentially other patients) would be secured from access by non-designated personnel and the general public until such time as the patient was discharged from the ED or was admitted to the hospital (at which time the medications would be sent to the Pharmacy for secure storage, as per policy, if no one was available to take the medications home). Leaving the medications on the table near the open door (which opened into a main ED hallway) provided the opportunity for access to these medications by anyone passing by the room.

Findings:

1. On 11/18/14 at 10:10 am another surveyor on the survey team noted that someone had placed a sealable plastic bag of a patient's medications on a table near the entrance to Room 5 in the Emergency Department. That surveyor noted that this bag would be easily accessible to anyone walking by the room. An examination of the contents of the bag by that surveyor indicated it contained labeled prescription bottles for Patient 24 labeled to contain macrodantin (an antibiotic), atorvastatin (a cholesterol lowering agent), omeprazole (lowers the levels of acid in the stomach), Flomax (used to facilitate urination in men with an enlarged prostate), prednisone (a glucocorticoid used to treat inflammation), Coumadin (a blood thinner), latanoprost eye drops (used to treat glaucoma), and timolol eye drops (used to treat glaucoma). During an interview of Emergency Department Director by that surveyor at that time he stated that medications located on the table in Room 5 would pose a problem for potential diversion. He stated that the medications should have been sent to the pharmacy or secured in the ED Medication Room. He stated that the patient in Room 5, Patient 24, was being admitted to the hospital.

On 11/20/14 a review of the ED Census Record, by this surveyor, documented that Patient 24 had been in the ED since 7:30 am on 11/18/14 until he was admitted to the hospital later in the day on 11/18/14.

On 11/20/14 at 8:17 am a review of Policy and Procedure H19 entitled MEDICATION: PATIENT'S OWN BROUGHT TO HOSPITAL (Formulated 12/95, Revised 6/2014) indicated that medications brought to the hospital by patients were to be sent home with the patient's family members or secured in the pharmacy.

On 11/20/14 at 8:35 am a review of Policy and Procedure H16 entitled MEDICATIONS: CONTROL, ORDERING & DISCHARGE (Formulated 12/25, Revised 9/11) indicated that medications brought into the hospital were to be sent to the pharmacy. There was nothing in either procedure as how to secure home medications in the ED while the patient was being treated in the ED.

On 11/20/14 at 8:44 during an interview of Nurse T in the ED, she reviewed Patient 24's EMR (electronic medical record) and reported that Patient 24 arrived at the hospital at 7:28 am on 11/18/14 and a nurse began the triage process at 7:29 am. She stated Room 5 was the "Critical Care Room" so she felt that Patient 24 must have been very ill. She felt that the pharmacist (who worked in the ED) may have put the medications on the table near the door.

On 11/20/14 at 8:58 am the surveyor inspected Room 5 and diagramed it in his field notes. Room 5 opened directly into the main ED hall. The door opening was quite large (about six to eight feet wide). Standing in the hall at the entrance to Room 5 the surveyor noted a table with drawers placed against the right wall about 3 feet from the entrance to Room 5.

On 11/20/14 at 9:05 am a review of the HOME MEDS reconciliation list with the Director of Pharmacy indicated that Pharmacist U had entered the medications into this list at 9:16 am on 11/18/14.

On 11/20/14 at 10:50 am during an interview of Pharmacist U in the pharmacy, he stated that when he entered medications into the HOME MED reconciliation list, he would look at medications that the patient brought in from home. He stated that he entered Patient 24's medications into Patient 24's HOME MED reconciliation list and that he had Patient 24's medications with him when he created the list. He stated that he then placed the medications on a table in Patient 24's ED room (Room 5). When shown the diagram that the surveyor had drawn in his notes, he indicated he placed the medications on the table placed against the right wall about 3 feet from the entrance to Room 5. He stated that he took the medications to the pharmacy later when the patient was admitted to the hospital. He stated that medications were to be placed in the locked ED Medication Room (while the patient was in the ED). He stated he was busy the morning of 11/18/14 and forgot to place Patient 24's medications in the locked ED Medication Room.

On 11/20/14 at 11:04 am during an interview of the Director of Pharmacy he stated there was no official procedure for storing medications in the ED until a decision was made to send the patient home or to admit the patient to the hospital.

Based on inspection of one out of three Adult Crash Carts (contains medication and equipment used to manage medical emergencies) in the Emergency Department (ED), and review of an internal content list inside a sealed tray placed in drawer #4, the hospital failed to ensure that the content list, that served as a label for the contents of the tray, accurately documented the first date to expire of the lubricating jelly found in the tray. The date on the content list was "5-2015" while inspection of the contents of the tray indicated that two out of the five lubricating jelly packets found in the tray had manufacturer expiration dates of "3-2015" (two months earlier than documented) with the potential that staff would not remove these packets before they expired and therefore an expired compound would be available for patient use. The content list served as a label for the products with the tray and therefore mislabeled the contents by documenting an inaccurate expiration date.

Findings:

1. On 11/21/14 at 9:31 a.m. during an inspection of one out of three Adult Crash Carts in the ED, the surveyor found five 2.7 gram packets of lubricating jelly inside a sealed blue tray that staff had placed inside drawer #4. The earliest expiration date printed these packets was "3-2015" (on two out of the five packets). The internal content list sealed into the tray that contained these packets documented that the earliest expiration date was "5-2015". This observation was verified by the Director of Pharmacy at that time during an interview.

Based on observation, staff interview, and document review, the hospital failed to ensure safe food handling practices as evidenced by: 1) two food service staff not wearing hair restraints to completely contain hair, 2) Patient food transported uncovered on medical unit. This failure resulted in a potential for cross contamination (bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) of food with human hair and cross contamination of uncovered food items during transport of patient meal tray from covered cart to patient rooms.

Findings:

1. Food employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that cover body hair, that are designed and worn to effectively keep their hair from contacting exposed food clean equipment, utensils, and linens; and unwrapped single serve and single use items. Food and Drug Administration (FDA) Food Code 2013.
On 11/18/14 starting at 10:45 am, Food Service Worker (FSW) 1 was observed preparing food. FSW 1 was wearing a cap with 4 to 5 inches of hair not confined and exposed over food. Cook 1 was observed concurrently with medium length hair outside the hair net.

Executive Chef concurrently confirmed the FSW 1 and Cook 1 should have all hair contained in hair covering. Executive Chef acknowledged it was his responsibility to supervise the food preparation staff to ensure the hair was contained and not able to contaminate food during preparation.

Review of staff education dated 2/17/14, covering personal hygiene stated "hair is to be sufficiently covered to prevent it from falling into food and keep from touching our hair." The sign in sheet indicated FSW 1 had attended the in-service.

2. On 11/18/14 starting at 12:15 pm on the tele unit, patient trays were observed being passed by nursing staff. Nursing staff were observed taking patient trays from the covered transport cart in front of the nursing station and carrying them approximately 30 to 40 feet down the hall to patient's rooms. The patient meal trays contained uncovered food items like jello and fruit cups.

In a ccncurrent interview, the Director of Food Service (DFS) acknowledged that the covered food cart should be moved room to room to ensure the patient meal trays, which had uncovered food items, were protected from cross contamination during transport. DFS acknowledged there was no policy to direct nursing staff on how to deliver patient meal trays in a sanitary way.

Based on observation, staff interview, and document review, the hospital failed to ensure menu and meals served, matched the approved diet manual nutrition adequacy standards as approved by the Medical Staff. Lack of a current and comprehensive diet manual that reflected hospital developed diets including nutritional adequacy of the diet may result in inaccurate guidance to dietary and hospital staff when meeting the nutritional needs of patients, further compromising medical status.

Findings:

The hospital diet manual is approved by the medical staff to ensure the diets offered meet the current standards of practice and include a comprehensive description of the therapeutic diets offered by including the purpose of the diet, indications of the diet, nutritional adequacy of the diet, and sample menu plans and standard of practice references.

Review of hospital Diet Manual titled, "Clinical Diet Manual by Food and Nutrition Management (6th edition)" approved by hospital medical staff committee on 9/2/14, showed the nutritional adequacy for the regular diet contained approximately 2,325 calories and 130 grams protein. The nutritional adequacy for the pureed (blended) diet showed it contained approximately 3100 calories and 151 grams protein. The sample menu used to determine the nutritional adequacy stated the lunch and dinner meat portions were to be 4 ounces each (approximately 28 grams protein).The pureed diet sample menu showed lunch and dinner serving 4 ounces each of pureed meat.

Observation of patient meal service and meal production sheet on 11/18/14 starting at 11:45 am, showed regular meatloaf entrée to provide 4 ounces and puree beef mold to provide 3 ounces. Review of manufacturer's content of puree mold beef entrée showed it contained 14 grams protein per one serving. The 14 grams protein equals approximately 2 ounces of protein. The clinical nutrition manager concurrently confirmed the puree entrée beef mold did not meet the specified portion.

Three slices meal loaf were weighed. The weights were 2.5 ounces, 3 ounces and 4 ounces. Concurrent interview with Clinical Nutrition Manager stated the meat loaf was to be 4 ounce portion. Review of the recipe for meatloaf showed it provided 16 grams protein.

Interview with the Director of Food Service (DFS) and Clinical Nutrition Manager (CNM) on 11/19/14 at 8:30 am, discussed the how patient menus and recipes used to prepare patient food accurately reflected nutritional adequacy of diet as stated in the hospital diet manual. The Clinical Nutrition Manager stated the diet manual was recently purchased from the company that provided the menu software and approved by the medical staff at that time. The CNM stated that she was not aware that the menus and recipes they used did not match the diet manual nutritional adequacy and sample menus. CNM stated the diet manual and menus were from the same company and she thought they matched but had not verified this. The CNM stated that her job included oversight patient portion control, menu analysis, and patient satisfaction standards. CNM confirmed that she needed to work with the diet manual and Software Company to ensure the nutritional adequacy of diets and sample daily menu plans stated in the diet manual were provided as approved by the medical staff.

Based on observation, staff interview, and document review, the hospital failed to ensure there was a system to provide emergency water as needed to provide care to in-patients, staff, and other persons who may come to the hospital in need of care. Failure to have adequate water for drinking and hygiene puts patient, staff, and visitors at risk of dehydration and compromised medical care.

Findings:

On 11/20/14 at 3:00 pm, the Trauma/Disaster Coordinator stated the emergency water was based on one gallon per person per day as specified by FEMA (Federal Emergency Management Agency). Hospital designated staff stated they planned for average daily patient census of 90 and average staff for a total of 350 persons per day. Designated staff stated emergency water was stored in the parking garage consisting of 500 gallons in 55 gallon drums.

The Trauma/Disaster Coordinator stated the safety committee had not discussed the water requirement to address additional water based on nursing assessment for medically compromised patient population, wound requirements, and other additional water during an emergency where water was not available.

Based on a minimum FEMA water requirement the hospital would require, for a minimum of 189 licensed beds and including approximately 260 staff, 449 gallons per day and 1,347 gallons for three days at a minimum. Other water requirements for medically compromised patients would add to the basic calculation.

Based on observation, interview, and document review, the hospital failed to ensure an effective, active system wide infection control program and surveillance for prevention, control, and investigation of infections and communicable diseases. The Infection Control, Condition of Participation is not met as evidenced by the hospital's failure to have effective systems in place to provide and ensure:

1. Active surveillance to identify policies and procedures that are not implemented correctly in an active infection control program. (refer to A-0748)

2. Sanitary condition of the Operating Room Suites environment. (refer to A-0748)
a. Failed to provide effective monitoring to ensure staff was trained and competent to effectively sterilize hinged surgical instruments, (refer to A-0749)
b. Failed to provide for and monitor material covering operating room equipment, (i.e. patient gurney, arm board; failed to maintain in a condition that would permit the equipment to be disinfected). (refer to A-0749)

3. The sterility of Surgical instruments and sterile supplies (refer to A-0749)
a. Failed to provide effective monitoring of sterile supplies and sterile surgical Instrument storage room. (refer to A-0749)
b. Failed to ensure Sterile supplies were maintained in accordance with facility policy regarding event-related sterility standard (refer to A-0749 and A-0748)

The cumulative effects of the above systemic problems resulted in the hospital's inability to provide an effective hospital wide infection control program; care in a safe and effective manner in accordance with the Condition of Participation for Infection Control Services.


On 11/19/14 at 12:55 pm, the Chief Executive Officer (CEO) and Chief Nursing Officer (CNO) were notified that an Immediate Jeopardy was declared for the widespread pattern of potential ineffective sterilization of hinged surgical instruments. The Immediate Jeopardy was abated on 11/20/14 at 2:30 p.m. with the CEO and CNO, after multiple practices in hinged surgical instrument sterilization were observed. On 11/20/14, following a meeting to discuss potential problems with the implemented corrected actions taken to ensure effective sterilization processes, the hospital modified and submitted their final corrective action plan, which was accepted.

Based on observation, interview, and document review, the hospital failed to ensure an effective, active, system wide, infection surveillance control program for prevention, control, and investigation of infections and communicable diseases.

1. The facility failed to provide Infection Control surveillance to identify significant deficiency in the staff knowledge regarding Infection Control concepts and procedures per facility policy and nationally identified standards identified as adopted by the facility. Its active surveillance failed to identify policies and procedures that were not implemented correctly in an active infection control program.


2. The facility failed to ensure integrated active system-wide infection prevention and control program into the facility QAPI (quality assessment and performance improvement) program.

These failures resulted in or had the potential to result in an increase in surgical site infections and cross contamination of communicable disease and infectious microorganisms.

Findings:

1. During entrance interviews on 11/18/20 at 10 am, the Infection Control Preventionist (ICP), OCR (Operating Room Coordinator), and DPI (Director of Performance Improvement), indicated the facility followed the national recognized standards: the Association of Perioperative Registered Nurses (AORN), the Association for the Advancement of Medical Instrumentation (AAMI), and the Center for Disease Control (CDC).

On 11/18/2014 at 1:30 pm, the ICP presented blank documents titled, "Infection Prevention and Control Departmental Environmnet of Care (EOC) Assessment tools," in response to a request for the last quarter completed environmental surveillance tools or any rounding tools. The completed tools for surveillance of the Operating rooms and sterile supply areas were not provided by exit. During a subsequent interview, the ICP stated, "well I do not always fill the tool out but "we" go to all those places".

CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 William A. Rutala, Ph.D., M.P.H. , David J. Weber, M.D., M.P.H.
Periodic infection control rounds to areas using sterilizers to standardize the sterilizer's use may identify correctable variances in operator competence; documentation of sterilization records, including chemical and biological indicator test results; sterilizer maintenance and wrapping; and load numbering of packs. These rounds also may identify improvement activities to ensure that operators are adhering to established standards989.


On 11/18/14 at 1:40 pm, a review of record titled, "Infection control program" indicated the facility was not following their own policy regarding the Infection Control Program for active surveillance. Under the subtitle, "Active Surveillance," dated 2014 and referring to "house-wide" surveillance was a bulleted statement, "ICP or designee(s) will conduct infection control round throughout the organization to identify and correct practice or environmental issues."

On 11/18/14 at 2 pm, an interview with the ICP was conducted regarding his knowledge of event related sterility. The ICP stated he did not know the term's meaning. The ICP indicated he did not know what system the hospital followed. However, after consulting with someone on the phone the ICP replied the hospital follows event related sterility.

A subsequent review of record on 11/18/14 at 2:20 of a facility policy titled, Event-Related Sterility, dated 6/14 revealed the hospital policy is to follow event related sterility. The policy states ... the storage methodology is to be checked for integrity of packaging on a daily, weekly and monthly basis. At exit, the requested documentation of surveillance was not provided.

2. An interview on 11/19/14 at 1:55 pm, was conducted with the Chief Executive Officer (CEO) and DPI. The CEO stated, "Our infection rates don't show it" in response to being informed of a break in policy regarding the processing of surgical instruments.

A review of records in the minutes of the quality committee minutes, the ICP reported a "significant increase in infection rates and readmits from Surgical Site Infections (SSIs)". The minutes revealed a plan of monitoring the infection rates and sending to Peer review. During a subsequent interview on 11/20/14 at 3 pm,the ICP indicated he was not aware of the outcome of the Peer review. The ICP also indicated he was not aware of any intervention planned to bring the infection rates down. The ICP was unable to find any further discussion in the minutes or elsewhere to indicate follow-up on SSI rates at time of exit.

Based on observation, staff interview, and document review the facility failed to develop effective systems for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in accordance with facility policy and nationally recognized infection control standards (NRS) and Center for Disease Control (CDC) guidelines.

The facility failed to ensure that:

1. Staff were competent on current standards of sterile processing, as evidenced by: hinged and ratcheted surgical instruments were not sterilized in the open position, un-ratcheted hinged instruments were not placed with tips open, hinged instruments were not placed in appropriate size peel packs, hinged instruments were not appropriately packed in double peel packs according to facility policy and nationally accepted standards, rigid trays were not loaded to ensure all instruments had maximum exposure to the sterilizing agent to ensure sterility, staff were not competent on current standards of selecting and loading technique of appropriate size rigid tray to accommodate contents and instruments to be sterilized, hinged instruments were not loaded on the appropriate size stringer, and surgical instruments did not have all surfaces available to sterilizing agent.

2. Staff were trained and competent to effectively disinfect the preoperative environment when restricted areas and traffic patterns in procedure areas were not identified and maintained in accordance with nationally accepted standards of practice, traffic pattern crossing the area known as the "pass through" of decontamination and sterile processing, the cleanliness of the area in semi restrictive area known as the "pass through," staff members were trained and competent to ensure the preoperative environment was effectively disinfected, staff members were trained and competent to ensure the operating rooms (OR) were effectively disinfected.

3. High level disinfection of endoscopes was not performed correctly when they were hung to dry in close proximity to decontamination processes with potential for cross contamination.

These failures resulted in the facility's inability to provide a functional and sanitary environment for the provision of surgical services, so that the types of surgery could be performed in a manner that protects the lives and ensures the physical safety of all individuals in the area as well as a safe environment free of transmission sources of infections and communicable disease


Findings:

1 a. On 11/19/14 at 9 am, in the General sterile processing room, rigid trays and peel packs (containers for holding instruments to be sterilized) were noted to have been loaded improperly with hinged instruments in closed position and some in the closed and locked position. A concurrent interview with the Infection Control Preventionist (ICP), Operating Room Coordinator (ORC), and Central Processing Staff (CPS)1 indicated these practices were typical, and acknowledged all hinged instruments on the facility campus should be pulled from stock and reprocessed with hinged instruments in the unlocked and open position and instruments should not be placed on top of each other. The Infection Control Preventionist (ICP), Operating Room Coordinator (ORC), Central Processing Staff (CPS) 1 each acknowledged the following observation of practices were inconsistent with facility policy and nationally recognized standards adopted and incorporated into facility policy. ICP, ORC, CPS1 acknowledged that Association of Perioperative Registered Nurses (AORN) and Advancement of Medical Instrumentation (AMMI) were the nationally recognized standards that the General Sterile Processing department rely on for facility policy and in the absence of facility policy.

In the sterile processing center on 11/19/14 at 10 am, CPS1 placed instruments in the closed and locked position in the rigid tray, 22 hinged instruments on a stringer 2 to 2.5 inches wide (a long three prong rod device when appropriate sized assists to hold hinged instruments in the open and unlocked position for sterilization), 15 of 22 hinged instruments were ratcheted and with tips locked, and 2 of 2 long scoped instruments were packed upon each other preventing sterilant from reaching all surfaces of the surgical instrument.

In a subsequent, interview on 11/19/14 at 12 pm, when CPS1 was asked why he packaged instruments in the closed and locked position, CPS1 stated, "That is how I learned to load them." CPS 1 indicated he had completed an online course to begin work in the area and then had received training on the job. CPS1 indicated that he had not received in-service training provided on packaging/positioning instruments.

b. During a tour of the Cardiovascular Operating Room (CVOR) at 11:10 am, ICP, ORC and PD each identified hinged instruments that were packed in peel packs ratcheted and closed. The peel packs were inconsistently packed with various breaks in standards as indicated by the following: 50 plastic trays placed on a 7 shelf cabinet, 50 of 50 plastic trays contained hinged instrument ratcheted and tips closed, and 24 of50 plastic trays contained hinged instruments improperly packaged in peel packs. In a concurrent interview, ICP, ORC and PD acknowledged that the hinged instruments were in a closed and locked position and sterility could not be ensured in that position.

On 11/19/2014 at 12:45 pm, during a tour of the preoperative area, with ICP, ORC and PD, a major procedure tray in the sterile supply room known as the "General Sterile room" was opened and inspected. The following observations were confirmed by the ICP, ORC and PD: One stringer contained 60 hinged surgical instruments, 56 of 60 hinged instruments were observed in closed position, and 12 of 60 hinged instruments were observed closed and locked.

On 11/19/14 at 2:30 pm with ICP, ORC and PD, a "lap tray" was opened and inspected in the sterile supply storage known as the "Neuro OR" located in the preoperative suite. The contents were consistent with previous rigid trays in that hinged instruments were sterilized in the closed position. In a concurrent interview, ORC and ICP again clarified this was the typical practice for loading rigid trays. Each staff member acknowledged the items could not be ensured to be disinfected with debris on the surface. Sterilization can be achieved only if the sterilizing agent (e.g., steam) contacts all instrument surfaces. Therefore, hinged instruments, such as hemostats, scissors, and extraction forceps, should be sterilized in the open position to ensure that the sterilizing agent adequately contacts all surfaces. Each acknowledged all rigid trays with hinged instruments and all peel packs in all hospital areas needed to be pulled, reprocessed, and sterilized.

Reference
Association for the Advancement of Medical Instrumentation, American National Standards Institute. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006. Arlington, VA: Association for the Advancement of Medical Instrumentation, 2006.

On 11/20/14 at 1:20 pm, during an interview with Director of Performance Improvement (DPI) person she stated a team was sent out to inspect all sterile surgical instrument storage. DPI stated, the team had been inspecting sterile instrument packages and found that all ratcheted instruments sterilized in peel packs had been found in the closed and locked position and all were being pulled from all hospital circulation and being reprocessed and sterilized according to national recognized standards.

c. In a concurrent review of policy, the hospital's policy titled "Instruments, Scope and Power Equipment, Care of", dated implemented 11/19/14, was reviewed. The Policy stipulated, "Instruments with removable parts should be disassembled and placed in storage trays or canisters designed for sterilization ...Ring handled instruments are to be secured in a manner that allows the box lock to remain in the open position ...Delicate and sharp instruments are to be protected according to the manufacturer's instructions. If wrapped in a peel must have a "plastic blunt tip cover to prevent package perforation and subsequent contamination."

According to AAMI- Sterilization can be achieved only if the sterilizing agent (e.g., steam) contacts all instrument surfaces. Therefore, hinged instruments, such as hemostats, scissors, and extraction forceps, should be sterilized in the open position to ensure that the sterilizing agent adequately contacts all surfaces.

Reference
Association for the Advancement of Medical Instrumentation, American National Standards Institute. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006. Arlington, VA: Association for the Advancement of Medical Instrumentation, 2006.


The 2014 Preoperative Standards and Recommended Practices published by AORN was reviewed. Direction was given that, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces and instruments with hinges should be opened..."

(AORN) Recommendation IV 2009-2014
Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. ...Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible.

IV.c.Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces.3 [3: Limited Evidence]
Sterilant contact is necessary for sterilization to be achieved.
IV.e. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer ' s written and validated IFU specifies that disassembly is not required.3 [3: Limited Evidence]
Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant.3
IV.f. Items to be sterilized that have concave or convex surfaces that create potential for water retention should be positioned within packages in a manner that prevents those surfaces from retaining water.3,4 [1: Strong Evidence]
Preventing water retention can help avoid the occurrence of wet packs and sterilization failure.
IV.g. Towels placed within instrument sets should be lint-free, freshly laundered, and thoroughly rinsed by a health care-accredited laundry facility. [3: Limited Evidence]
Adequate rinsing reduces the risk of leaving chemical residues that could be transferred from the towels to instruments.28 Lint left on sterile instruments may be transferred to the surgical wound and may cause a foreign-body reaction.
IV.h. Items to be sterilized should be placed in the package or tray in an open or unlocked position. [3: Limited Evidence]

On 11/18/14 a tour of the General Sterile Supply room revealed instruments and supplies stored inconsistent with the facility's policy of storage of sterile supplies and surgical instruments utilizing the event related sterility method (Event Related Sterility-Sterility determined by how a package is handled rather than time elapsed; a package is considered sterile until opened or the integrity of packaging material is damaged.)

A review of records indicated the facility was to follow the AORN standards for Event Related Sterility.

A review of AORN standards 2014 revealed the instruments and supplies were stored inconsistent with the AORN standards for event related sterility page 590 of AORN standards 2014.

AORN 2014 Events that could compromise package sterility may arise from:
the type(s) of packaging materials or packaging system in use
package design
the after effects of any failure(s) during cleaning and/or sterilization of the item(s)
conditions occurring during storage and handling eg packaging damage, soiling, becoming wet, exposure to vermin, etc.
Materials deterioration of the product or its component parts·
Compression
Traffic and Staff handling control.
The after effects of any failure(s) during cleaning and/or sterilization of the item(s) As part of the quality management process, any or all of these factors may be altered to improve the likelihood of maintenance of sterility for long lengths of time. Another factor important in establishing an ' event related sterility regime ' is education of all personnel involved in handling sterile stock, including users (medical and nursing personnel).

In practice, the introduction of an event related sterility regime is a major exercise involving detailed assessment of all areas in which sterile stock is stored. There is a need to both influence and control the conditions of storage and all handling ' experiences ' endured by stock during storage.


d. In a subsequent interview on 11/20/14 at 2:45 pm, CPSup (Central Processing Supervisor) acknowledged the problem identified with staff sterilizing surgical instruments in the closed and locked position was ultimately his responsibility.
CSPsup indicated, he was familiar with national sterilization guidelines, but that he disagreed with the standards. When interviewed further, CSPsup acknowledged he understood that it was not acceptable to sterilize hinged and ratcheted instruments in a closed and locked position.

ICP stated, "staff also needed more specific ongoing in-service training along with annual competency checks that looked in detail at processing skills. "

On 11/21/14 at 9 am, during a review of five records for infection control training with Director of Human Resources (DHR), four did not reveal job specific infection Control training.

2 a. On 11/19/14 at 10 am, during a tour of the preoperative unit (PASS) and OR, "pass" room (room #247) was observed. The ICP verified the room was terminally cleaned and ready for the next patient. The room was found to have ¼ thick dust cover on back boards and shelves, a metal arm that hung over the bed and housed the wires and held the TV screen had a four inch wide tape wrapped four times around the arm, the refuse container was not empty, the gurney was visibiliy soiled on the bed handles, frame and wheels, the mattress pad had strips of sticky substance in the upper right and left corners.

During a concurrent interview the ICP, Enviromental Services Staff (EVS1) and the PD were in agreement that the room was not cleaned and prepared for occupation by a surgery patient.

During a subsequent interview with EVS1 regarding the cleaning procedures. EVS1 stated the facility uses one cleaner called "Activate." EVS1 stated she believed the dwell time (in contact with the surface to be disinfected) was two minutes. The EVS1 stated, "the cleaner is a one step cleaner/disinfector".

A review of the manufacturer's technical information sheet for the e.p.a. registered one-step hospital disinfectant called "Activate" indicated the product was highly effective against a broad spectrum of pathogens when used as directed. The instructions indicated that to be effective the product solution needed to be in contact with the surface for four (4) minutes. In addition, if seen or unseen bio debris existed then a two-step process is necessary.

b. On 11/19/2014 at 9:00 a.m., in a tour of the Central Processing area, an observation was made of the a staff member in the decontamination room remove his Personal Protective Equipment (PPE) and then walk directly through into the sterile process from the decontamination room. The staff member failed to perform hand hygiene.

On 11/19/2014 a concurrent review of facility policy titled, "Decontamination Process," dated, 2014. indicated, staff working in and moving from the decontamination room will not pass from the decontamination room directly into the sterile supply room.

Dudring a concurrent interview, on 11/19/14 at 9 am, the ICP indicated he does not know the facility policy but the sterile central processing unit follows AORN.

A Review of The Preoperative Standards and Recommended Practices published by the AORN (Association of preoperative Registered Nurses), 2014 edition indicated "Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. The semi-restricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and patients. The restricted area includes operating rooms, procedure rooms, and the clean core area. "

c. On 11/19/2014 at 2:50 pm, during the tour of the facility and the Operating Rooms, OR room 5's mattress was observed to have tape residue in the top 1/3 of the mattress with two by three to four inch patches of residue running horizontal across the top of the pad and a strip down the side of the mattress. In a concurrent interview, the ICP stated, "this should not be here." In an interview with ORC at 2:54 pm, it was confirmed that terminal cleaning was completed the night before and the Environmental Services staff (EVS) believed the OR room to be ready for surgery. ORC acknowledged the tape residue should not be left on the mattress pad. EVS stated, staff should know to completely clean the mattress.


3. On 11/21/14 at 9:12 am, a tour of the endoscope processing center was conducted. The endoscope processing room was immediately adjacent to where endoscopes were cleaned and decontaminated. The areas were both located side by side within the same room. In a concurrent interview, ICP indicated he did not have any idea of the proper set up for decontamination and cleaning of endoscopes. ICP indicated the hospital policy was to follow the AORN standards for the endoscope area. However, ICP acknowledged the cross contamination possibility. ICP verbalized the structure issue is, "The high level disinfected instruments that were immediately adjacent to the sink and hung to dry in the same processing area".

A review of the 2014 AORN Standards and Recommended Practices, under Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories was conducted and provided the following information:
" Flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled and patient care activities are performed. Physical separation of decontamination areas from areas where clean items are handled minimizes the risk of cross-contamination. Cross-contamination can result when soiled items are placed in close proximity to clean items or placed on surfaces upon which clean items are later placed. Aerosols created during cleaning can also cause cross-contamination. The decontamination area should be physically separated from clean patient care areas and include a door. This area should contain, but not be limited to: sinks to manually clean flexible endoscopes, hand-washing facilities, eyewash station, automated equipment consistent with the types of flexible endoscopes to be decontaminated, adapters and accessories to connect the flexible endoscopes with cleaning equipment and utilities, leak testing equipment, low-pressure air, closed storage facilities, and proper ventilation. The design of the decontamination area facilitates the safe and effective decontamination of flexible endoscopes and accessories. Appropriate equipment and utilities facilitate desired infection control practices.



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7. On 11/18/14 starting at 11:00 a.m., Engineer 1 stated the internal components of the kitchen ice machine were cleaned and sanitized by the engineering department preventative maintenance program. Engineer 1 stated and displayed a product called nu-calgon cleaner and nu-calgon sanitizer.

A review of the manufacturer's directions publication number 630460174SER, for this ice machine brand, stated the sanitizer was household liquid bleach (50 parts per million chlorine) to be mixed one ounce per gallon room temperature water and two minute exposure time.

Engineer 1 confirmed that he did not use household bleach as directed in the manufacturer's directions.



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8. During the initial tour of the orthopedic unit on the fourth floor on 11/18/14 starting at 10 am with the Director of Performance Improvement (DPI), one of 20 patients was observed to have an infection control concern in their room (Patient 5).

Patient 5 had a CPM (continuous passive motion, a device placed on the leg following knee surgery) stored in her room on the floor.

The DPI confirmed the observations and stated that she was unsure whether that piece of equipment should be left on the floor.

During a concurrent interview and observation with Registered Nurse (RN) C at 11/18/14 at 10:40 am, she stated that the CPM is supposed to be placed on a hook that is located on the patient's wall in order to prevent the device from coming in contact with the floor and then being placed into the patient's bed when being placed on their leg for treatment. RN C confirmed that placing stuff on the floor and then into the patient's bed presents some obvious infection control concerns.

Based on medical record review and staff interview, the facility failed to ensure that operative reports were dictated immediately following surgery, according to medical staff rules.

Findings:

On 11/18/14, the Medical Staff Bylaws, Rules and Regulations, effective 3/25/14, were reviewed. Section 5, Operative Report (page 96) stated in part: "Operative reports shall be dictated within 24 hours following surgery for outpatients as well as inpatients and the report promptly signed and dated by the surgeon .... "

The following medical records were reviewed on 11/21/14 and the findings concurrently confirmed by staff Health Information Management Tech A: The operative report in Record 34 was dictated on 10/22/14 for the outpatient surgery performed on 10/17/14. In Record 42, the cardiac catheter procedure was performed on 8/26/14 and the report was dictated on 9/15/14. This patient then had a cardiac bypass operation performed on 8/28/14 and the report was dictated on 8/31/14.