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Based on 3 of 12 MR reviewed (Pt. #12, 29, and 33), P&P review, 1 of 1 observations, 3 of 3 credential files reviewed, and 7 of 7 interviews with facility staff, the GB (governing body) failed to ensure that it assume responsibility for the hospitals total operation and that services are provided in accordance with acceptable standards of practice and hospital P&P. This affects all hospital patients.

Findings include:

The GB failed to ensure that surgical physician assistants (RN, PA, NP, technicians) are granted surgical privileges and that the surgical services department maintain a current roster of practitioners specifying the surgical privileges of each practitioner.

Immediate Jeopardy was identified on 1/25/12 when GB was unaware that surgical physician assistants, who are not hospital employees, were performing surgical tasks without hospital privileges. Immediate jeopardy was removed on 1/25/12 when the unprivileged assistants were removed from surgical rotationsB failed to ensure that surgical patients are protected from fire. Tag A-940

The GB failed to ensure the hospital environment is safe. See A700.

The GB failed to ensure the hospital environment is sanitary and free from potential sources of infection. See A747.

The cumulative effect of these systemic problems resulted in the facility's inability to protect all patients and ensure safe and optimal patient care.

Based on MR review, staff interview, P/P review and review of the facility's standards of care for postpartum and newborn, this facility failed to complete individualized care plans for 2 out of 3 obstetrical (OB) records (Pt. #1 and #3), 2 out of 3 newborn records (Pt. #4 and 6), and 2 out of 14 medical/surgical (med/surg) records (Pt. #17 and 26) out of a total sample of 33 MRs.

Findings by Surveyor #26711:

The facility's policy titled, "Interdisciplinary Plan of Care (IPOC), Acute Care," dated February 2009, was reviewed with CNO A on 1/26/2012 at 11:45 a.m. The policy statement states, "All admitted patients will have a plan of care specific to their needs."
In the section titled Instruction, #3 states, "Based on the initial assessment, an RN or other authorized personnel (with patient involvement as appropriate) shall identify problems and develop the individual plan of care for the patient."
In this same section, #4 a. states, "Goals should be measurable and attainable and directed at resolving the patient problem."

The facility's policy titled, "Nursing Documentation: Admission Assessment and Reassessment," dated April 2008, was reviewed on 1/26/2012 at 11:45 a.m. with CNO A. The policy states in part, in the section titled Special Instructions, "#3. Patients shall receive care based on a comprehensive admission assessment of needs. The appropriate assessment form shall be initiated at the time of admission to the facility and completed within 24 hours following admission."

A tour of the OB unit was conducted on 1/24/2012 at 9:30 a.m. with Lead RN VV and CNO A. During the tour Lead RN VV stated that normal deliveries-moms and babies-only get care plans if there is a problem, otherwise they follow their standards of care.

During the time of MR review (1/24/2012 at 1:35 p.m. accompanied by HIM staff X), Surveyor #26711 spoke with Lead RN VV, after HIM staff X spoke with VV, for further clarification regarding nursing care plans for maternity patients. Lead RN VV again stated, "The standards are posted on the unit. They are currently not part of the record. There is no care plan on file unless there is a problem."

A MR review was completed on Pt. #1's closed OB record on 1/24/2012 at 1:20 p.m., and on Pt. #2's closed OB record on 1/24/2012 at 2:00 p.m. in the presence of HIM staff X.

There are no nursing care plans for Pt. #1 ( a vacuum assisted vaginal delivery), or Pt. #2 (a spontaneous vaginal delivery).

A MR review was completed on Pt. #4's closed newborn record on 1/24/2012 at 2:17 p.m., and on Pt. #6's closed newborn record on 1/24/2012 at 2:40 p.m. in the presence of HIM staff Y.

Pt. #4 had difficulties with low blood sugar for several hours after birth. Pt. #4's Apgar scores (a clinical measure that determines the health of a newborn performed by the RN at 1 and 5 minutes after delivery, 0 is very poor-absence of life, and 10 is the best score) were 5 after 1 minute and 9 after 5 minutes.
Pt. #4 did not have a nursing care plan.

Pt. #6 also did not have a nursing care plan in the MR.

These findings were confirmed a the time of the MR with HIM staff X and Y, and again with CNO A on 1/26/2012 at 11:45 a.m.

In an interview with CNO A on 1/26/2012 at 11:45 a.m., the facility's standards of care for postpartum and newborn patients were reviewed. These standards are dated to be effective 12/2011. The standards are posted within the OB unit and are to be followed for deliveries. These standards are not part of the MR, they are not a nursing care plan, and they are not individualized to each patient.

A MR review was completed 1/25/2012 at 9:10 a.m. on Pt. #17's closed MR. Pt. #17 was admitted to the facility as an observation patient on 10/20/2011 at 1:45 p.m. The "Short Form" for admission was started upon Pt. #17's arrival to the med/surg floor. According to CNO A (on 1/26/2012 at 11:50 a.m. there are two assessment forms for nursing. A short form is for anticipated short stays and the "Long Form" is for anticipated stays of more than one day.

The back side of the form, which includes areas for nursing documentation regarding procedures and plan of care, is blank.

Pt. #17 was admitted as a regular inpatient on 10/3/2012. The nursing care plan does related to Congestive Heart Failure does not have a patient goal.

This finding was confirmed by HIM staff Y and Dir. W during the time of the MR review, and again by CNO A on 1/26/2012 at 11:50 a.m.

A MR review was completed on 1/25/2012 at 2:35 p.m. on Pt. #26's closed MR. Pt. #26 was admitted with shortness of breath. The nursing care plan indicates that Pt. #26's clinical problems are hypoxia (low oxygen in the blood), and an exacerbation of Congestive Heart Failure and Chronic Obstructive Pulmonary Disease.

Pt. #26's goal is written as follows (staff's abbreviations are spelled out for clarity): "Pt. will be back to respiratory baseline (home oxygen levels with no increasing shortness of breath) by discharge."

There is no indication of what Pt. #26's "baseline" is for oxygen levels or shortness of breath, making this goal non-measurable.

This finding was confirmed a the time of MR review by HIM Dir. W and again on 1/26/2012 at 12:00 p.m. by CNO A.

Based on MR review, P/P review, and staff interview, this facility failed to ensure that all entries in the patient's MR are complete and accurate and that all entries include dates, times, titles, and/or signatures in 11 out of 33 MR reviewed (Pt's #12, 17, 19, 20, 22, 24, 27, 30, 31, 32, 33).

Findings by Surveyor #26711 include:

The facility's policy titled, "Medical Record Regulations," dated February 2011, was reviewed on 1/26/2012 at 10:00 a.m. On page 3, III. Documentation-General Requirements, 3.1 b. states, "Entries shall be accurately written and represent the care/services provided."

In this same policy, 3.1 c. states in part, "Entries are authenticated by the person making the entry as follows: 1. Medical Staff appointees by recognizable signature, initials, or electronic signature."

In this same policy, 3.1 d. states, "Medical record entries are legible, dated, and timed."

On page 5 of this policy, section 3.8, Delinquent records, b. states, "A medical record is considered delinquent when it has not been completed within fourteen (14) days after the patient's discharge."

On page 20 of this policy, section 5.12 d. states, "Progress notes must be dated, timed and signed."

A MR review was completed on Pt. #17's closed inpatient record accompanied by HIM Dir. W on 1/25/2012 at 9:10 a.m. A release of information form, signed by Pt. #17 on 10/2/2011 does not indicate the time the hospital staff witnessed the signature. The discharge instruction form, signed by Pt. #17 on 10/4/2011 does not include the time hospital staff obtained Pt. #17's signature.

This finding was confirmed by CNO A on 1/26/2012 at 11:50 a.m.

A MR review was completed on Pt. #27's closed inpatient record accompanied by HIM Coord. U on 1/25/2012 at 2:51 p.m. The discharge instruction form, signed by Pt. #27 on 11/12/2011 does not include the time hospital staff obtained Pt. #27's signature. The Anesthesia record, dated 11/11/2011 does not include a time for the pre-anesthesia evaluation (eval).

This finding was confirmed by CNO A on 1/26/2012 at 12:00 p.m.

A MR review was completed on Pt. #30's closed operation room (OR) record accompanied by HIM Coord. U on 1/26/2012 at 8:47 a.m. Pt. #30's Post Anesthesia Eval form, dated 10/2/2011 does not include the title of the writer.

A MR review was completed on Pt. #31's closed OR record accompanied by HIM Coord. U on 1/26/2012 at 9:11 a.m. Pt.#31's Anesthesia record, dated 10/7/2011 does not include a time for the pre-anesthesia eval.

A MR review was completed on Pt. #32's closed OR record accompanied by HIM Coord. U on 1/26/2012 at 9:21 a.m. Pt. #32's OR record does not include a time it was completed on the bottom of the back side of the form. The Operation Report, signed on day 15, does not include a time the MD signed the report.

A MR review was completed on Pt. #33's closed OR record accompanied by HIM Coord. U on 1/26/2012 at 9:42 a.m. The Physician Outpatient order form dated 12/5/2011 does not include a date or time the MD signed the form. Pt. #33's Anesthesia record, dated 12/5/2011 does not include a time for the pre-anesthesia eval.

These findings were confirmed on 1/26/2012 at 12:15 p.m. with CNO A.




26390

Findings of surveyor #26390:

On 1-24-2012 at 2:29 PM the closed record for pt. #12 was reviewed with HIM Coord., U. The record showed a OR Record dated 11-14-11 with no time next to the surgeons signature.

On 1-25-2012 at 8:32 AM the closed record for pt. #19 was reviewed with HIM Coord., U. The record showed an Initial Pain Assessment Tool with no date/time of completion.

On 1-25-2012 at 10:50 AM the closed record for pt. #20 was reviewed with Dir. HIM, W. The record showed a Nursing Plan of Care- Safety/Falls, 2 pages with no date.

On 1-25-2012 at 11:37 AM the closed record for pt. #22 was reviewed with HIM Coord., U. The record showed an OR record dated 11-14-11 with no time next to the surgeons signature.

On 1-25-12 at 2:15 PM the closed record for pt. #24 was reviewed with Dir. HIM U. The record showed a Pain Management Flow sheet with no date. The Emergency Department Patient Record dated 9-28-11 was without the date and time of the assessing RN's signature.

The above findings were reviewed with Regulatory Compliance RN, B on 1-26-11 at 11:45 AM.

Based on MR review, P/P review, and staff interview, this facility failed to obtain the appropriate signatures, dates, and/or times on physician orders and telephone/verbal orders in 13 out of 33 MR reviewed (Pt's #1, 4, 5, 12, 15, 19, 20, 21, 22, 23, 24, 27, and 30).

Findings include:

The facility's policy titled, "Medical Record Regulations," dated February 2011, was reviewed on 1/26/2012 at 10:00 a.m. On page 3, 3.1 c. states in part, "Entries are authenticated by the person making the entry as follows: 1. Medical Staff appointees by recognizable signature, initials, or electronic signature."

In this same policy on page 3, 3.1 d. states, "Medical record entries are legible, dated, and timed."

On page 17, 5.8, Patient Care Orders, a. Inpatient Orders, 1. states, "Inpatient verbal and telephone orders are dated, timed and authenticated within 48 hours by the Medical Staff Appointee/Allied Health Professional responsible for ordering, providing or evaluating the service."

A MR review was completed on Pt. #1's closed maternity record accompanied by HIM staff X on 1/24/2012 at 1:20 p.m. On 9/4/2011 there is a telephone order (T.O.) that is not dated or timed by the MD.

A MR review was completed on Pt. #4's closed newborn record accompanied by HIM staff X on 1/24/2012 at 2:17 p.m. On 9/4/2011 there are three T.O.s that are not dated or timed by the MD.

A MR review was completed on Pt. #5's closed newborn record accompanied by HIM staff X on 1/24/2012 at 2:30 p.m. There is a verbal order (V.O.) dated 7/1/2011 that was not signed by the MD until 7/20/2011, a time period of 17 days.

A MR review was completed on Pt. #15's closed Emergency Department (ED) record accompanied by HIM staff Y and HIM Coord. U on 1/25/2012 at 8:34 a.m. On 12/1/2011 there is a V.O. for an anti-nausea medication that was not signed by the MD.

A MR review was completed on Pt. #27's closed inpatient record accompanied by HIM Coord. U on 1/25/2012 at 2:51 p.m. Pt. #27 had T.O.s on 11/11/2011 and 11/12/2011 that were not signed by the MD until 12/3/2011, a time period of 19 and 20 days. There are also Post Anesthesia Care Unit orders dated 11/11/2011 that do not include the time the MD signed the form.

A MR review was completed on Pt. #30's closed operation room (OR) record accompanied by HIM Coord. U on 1/26/2012 at 8:47 a.m. There are two orders written by a Nurse Practitioner, one on 10/4/2011 and one on 10/5/2011, that were not countersigned by the MD until 10/19/2011, a time period of 14 and 15 days.
In an interview with HIM U at the time of Pt. #30's MR review, U stated that there is still a 48 hour requirement for a MD signature on these orders.
There is also a T.O. written by an RN 10/5/2011 that was not signed by the MD until 10/18/2011, a time period of 13 days.

These findings were confirmed by CNO A on 1/26/2012 between 11:45 a.m.-12:30 p.m.


26390

Findings of surveyor #26390:

On 1-24-2012 at 2:29 PM the record for pt. #12 was reviewed with HIM Coord., U. The record showed one verbal order dated 11-17-2011 signed by the physician 3 days late. One telephone order dated 11-16-2011 with a physician signature but no date/time.

On 1-25-2012 at 8:32 AM the record for pt. #19 was reviewed with HIM Coord., U. The record showed 1 verbal order dated 11-17-2011 signed by the physician 3 days late.

On 1-25-2012 at 10:50 AM the record for pt. #20 was reviewed with Dir. HIM, W. The record showed 1 verbal order dated 10-17-2011 with a physician signature 9 days late, 1 telephone order dated 10-17-2011 signed by the physician 6 days late.

On 1-25-2012 at 11:16 AM the record for pt. #21 was reviewed with Dir. HIM, W. The record showed 1 telephone order dated 12-03-2011 with no physician signature, 2 verbal orders dated 12-2-2011 signed by the physician 13 days late, 1 telephone order dated 12-2-2011 signed by the physician 17 days late, 1 telephone order dated 12-1-2011 signed by the physician 5 days late, 1 telephone order dated 11-12-2011 signed by the physician 25 days late.

On 1-25-2012 at 11:37 AM the record for pt. #22 was reviewed with HIM Coord., U. The record showed eight telephone order's signed late. Telephone order dated 11-15-11 was signed by the physician two days late, three telephone orders dated 11-11-11 were signed by the physician 9 days late, telephone order dated 11-12-11 was signed by the physician 8 days late, telephone order dated 11-13-11 was signed by the physician 7 days late, telephone order dated 11-14-11 was signed by the physician 6 days late, on 11-14-11 two orders were written and were without physician signatures, telephone order dated 11-15-11 was signed by the physician 5 days late.

On 1-25-2012 at 1:29 PM the record for pt. #23 was reviewed with Dir. HIM, W. The record showed 1 verbal order signed by the physician 32 days late, and 2 telephone orders written on 8-20-2011 with no physician signatures.

On 1-25-12 at 2:15 PM the record for pt. #24 was reviewed with Dir. HIM U. The record showed a telephone order dated 9-29-11 signed by the physician 23 days late, telephone order dated 10-1-11 was signed by the physician 21 days late.

The above findings were reviewed and confirmed with Regulatory Compliance RN, B on 1-26-12 at 11:45 AM.

Based on 3 of 3 observations , P/P review, and 2 of 2 staff interviews (P and B), the hospital failed to ensure that drugs are prepared and administered using safe processes to prevent adverse drug events according to hospital P/P. Failure to adhere to medication safety protocols has the potential to affect all patients entering the operating rooms and post-anesthesia care unit, this includes the 49 patients scheduled for surgery between 1/23/2010-1/26/2012.

Findings include:
Examples by surveyor #13469:

Per P/P review, on 1/26/12 in the AM the Medication Administration P/P effective date April 2011 directs the following: "F. When a medication or solution is transferred by a caregiver from the original package to another container: 1. It must be administered immediately or it must be appropriately labeled by the caregiver. 2. Labeling specifics: a. Medications or solutions prepared on a patient care or treatment area will be labeled with the following information: i. Medications name, ii. Medication strength or concentration, iii. Initials of person preparing the medication, iv. Expiration date and time. 3. No more than one type of medication or solution is labeled at one time. 4. Any medications or solution found unlabeled are immediately discarded. 6. e. All original medication or solution containers will remain available for reference in a procedure area until the conclusion of the procedure. f. Any remaining medication or solution used during a procedure is discarded at the conclusion of the procedure."

Syringes are not prepared and labeled per hospital P/P:

Per observation, while touring the post-anesthesia recovery room with OR Manager (P) and RN, RC (B) on 1/24/12 at 10:30 AM, a supply cart used at patient bedsides during the recovery phase had a syringe labeled as containing Fentanyl 100 mcg/2 ml which is a Schedule II drug found in the top drawer. The partially used syringe contained 3 cc of Fentanyl out of a 10 cc syringe. A second syringe found in the drawer was labeled as containing 0.9% Sodium chloride. Three cc out of a 10 cc syringe remained in the syringe. The syringes did not include the the patient's name, date, time or initials of the person who prepared the syringe. Per interview with OR Manager (P), unused portions of any medication are supposed to be discarded after each case. Per OR Manager (P), the syringes were not labeled according to hospital P/P.

Per observation, during the preparation of surgery for patient #28 on 1/24/12 at 8:25 AM with OR Manager (P) and RN, RC (B), Anesthesiologist (R) prepared medications to be used for anesthesia. Dexamethazone was drawn from a multiple-dose vial and the unused portion of the vial was placed back into the anesthesia cart. Propofol was then drawn up into a syringe and the vial discarded into a waste basket. (R) proceeded to then affix labels of the drugs to the syringes one after the other. Neither syringe label contained the date, time, or initials of the person who drew up the medications. Propofol has a 6 hour use time. The vials were not kept available for reference next to the syringes until after the procedure was complete.

After Pt. #28 had left the OR suite, and during the time staff were cleaning up the room and setting up for the next case, CRNA (S) entered the room and proceeded to draw up medications for the next case. CRNA drew up Propofol, Versed and Zofran in succession. Each syringe was not labeled before the next medication was drawn. The syringe labels did not contain a date, time or initials once the labels were affixed to the syringe. The Zofran did not identify the dose contained in the syringe. Vials from which they were drawn were discarded immediately and not kept for reference during the surgical procedure.

The above examples were confirmed in interview with Manager (P) and RN, RC (B), following the observations on 1/24/12.

Based on 1 of 1 observation, 2 of 2 staff interviews (B and P), and P/P review by surveyor #13469, the hospital failed to ensure that Schedule II drugs are secured from unauthorized access. Failure to adhere to medication safety protocols has the potential to affect all patients entering the post-anesthesia care unit, this includes the 49 patients indicated on the surgery schedule between 1/23/2010-1/26/2012.

Findings include:

Per review, of hospital P/P Medication:Securing Controlled Substances effective date September 2011 on 1/26/12 in the AM, the policy directs the following: "III. Maintenance of Narcotics/Controlled Substances for Incremental Dosing: B. controlled substances must not ever be left unattended. They may be brought to the bedside for use during procedures, emergency situations, or during the immediate postoperative recovery period. C. Controlled substances must be under the direct observation of the clinician caring for the patient at all times. D. Once the procedure, emergency situation, or immediate postoperative recovery period is completed and/or the patient no longer requires frequent and immediate administration of the agents, controlled substances that are not used must be wasted. E. Medications should be labeled with patient name according to Medication Administration policy."

Per observation, while touring the post-anesthesia recovery room with OR Manager (P) and RN, RC (B) on 1/24/12 at 10:30 AM, a supply cart used at patient bedsides during the recovery phase had a syringe labeled as containing Fentanyl 100 mcg/2 ml which is a Schedule II drug found in the top drawer. It should be noted that this cart was sitting alone and not at a patient bedside at the time of the observation The partially used syringe contained 3 cc of Fentanyl out of a 10 cc syringe. The syringe did not include the the patient's name, date, time or initials of the person who prepared the syringe. Per interview with OR Manager (P), unused portions of any medication are supposed to be discarded after each case. Per (P), Schedule II drugs are to be secured and not left unattended to prevent unauthorized access per policy and procedure.

Based on observation, staff interviews and review of maintenance records on January 24, 2012 through January 30, 2012, the hospital failed to construct, install and maintain the building systems to ensure a physical environment that was safe for all patients, staff, and visitors.

Findings include:

The hospital failed to maintain adequate HVAC system. See A701.

The hospital failed to maintain an environment safe from fire. See A709 and Ktags for details:

(K-12) Building Structure; (K-17) Corridor Walls; (K-18) Corridor Doors; (K-20) Shafts/Stairs/Exit Passageways; (K-22) Exit Signs; (K-25) Smoke Barriers; (K-27) Smoke Barrier Doors; (K-29) Hazardous Spaces; (K-38) Egress; (K-46) Emergency Lighting; (K-56) Sprinkler System Installation; (K-62) Sprinkler Maintenance & Testing; (K-67) HVAC Installation & Testing; (K-71) Chutes; (K-74) Cubical Curtains; (K-76) Medical Gas Systems; (K-104) Duct Maintenance thru Fire Barriers; and (K-147) Electrical Requirements.

The cumulative effects of the environmental deficiencies result in the hospital's inability to ensure a safe environment for all patients, staff and visitors.

Based on observation and interview, the facility did not provide a code compliant HVAC environment with a properly designed HVAC system. This deficiency occurred in 2 of the 26 smoke compartments, and had the potential to affect all inpatients, outpatients, staff and visitors within the affected smoke compartments.

Findings include:
1. On 01/25/2012 at 11:30 am surveyor #18107 observed in the 1A smoke compartment on the 1st floor in the Bacteriology Lab in far Southeast corner of Clinical Laboratory, that the Bacteriology Lab Room was required to be negative to the surrounding spaces due to the infectious elements that are being tested in laminar flow hoods within the space. According to Guidelines for Construction and Equipment of Hospital and Medical Facilities, 1983 edition, in association with the US Department of Health and Human Services, DHHS publication #HRS-M-HF, this room shall be designed to a minimum of 6 air changes per hour and the air movement must be (in) with relationship to adjacent areas (negative pressure). The air cannot be recirculated and must be directly exhausted to the outside. When a tissue was placed next to the door with a slight crack, the tissue did not blow into the room as required from adjacent spaces. This observed situation was not compliant with CFR 482.41 Physical Environment, CFR 482.41(a) Buildings requirements and CFR 482.41(c)(2) Facilities and Equipment must be maintained to ensure an acceptable level of safety and quality. The condition was confirmed at the time of discovery by a concurrent observation and interview with staff C (Director Plant / Facilities), staff D (Analysis Quality), staff E (Director Safety), and staff F (Manager Facilities Srvcs.).

2. On 01/25/2012 at 3:20 pm surveyor #18107 observed in the 1D smoke compartment on the 1st floor in the Clean Equipment Holding Room #1128, that the 'Negative Pressure Box' was not identified and could have been shut-off, compromising the infection control / isolation room. This observed situation was not compliant with CFR 482.41 Physical Environment, CFR 482.41(a) Buildings requirements and CFR 482.41(c)(2) Facilities and Equipment must be maintained to ensure an acceptable level of safety and quality. The condition was confirmed at the time of discovery by a concurrent observation and interview with staff C (Director Plant / Facilities), staff D (Analysis Quality), staff E (Director Safety), and staff F (Manager Facilities Srvcs.).

Based on observation, staff interviews and review of maintenance records on January 24, 2012 through January 30, 2012, the hospital failed to construct, install and maintain the building systems to ensure a physical environment that was safe for all patients, staff, and visitors.

Findings include:
The hospital was found to contain the following physical environment deficiencies. Refer to the full description at the cited K-tags:

(K-12) Building Structure; (K-17) Corridor Walls; (K-18) Corridor Doors; (K-20) Shafts/Stairs/Exit Passageways; (K-22) Exit Signs; (K-25) Smoke Barriers; (K-27) Smoke Barrier Doors; (K-29) Hazardous Spaces; (K-38) Egress; (K-46) Emergency Lighting; (K-56) Sprinkler System Installation; (K-62) Sprinkler Maintenance & Testing; (K-67) HVAC Installation & Testing; (K-71) Chutes; (K-74) Cubical Curtains; (K-76) Medical Gas Systems; (K-104) Duct Maintenance thru Fire Barriers; and (K-147) Electrical Requirements.

Based on observation, P/P review, and 3 of 3 staff interviews (F, B, FFF), this facility failed to secure cleaning chemicals in soiled utility rooms from unauthorized access in 3 of 10 departments observed (Intensive Care Unit-ICU, Respiratory Therapy Department-RT, and Obstetrics-OB). Failure to secure cleaning chemicals has the potential to affect all patients and visitors who might access these chemicals.
The facility also failed to secure unauthorized access to 1 of 1 Surgical departments and ensure that surgical staff are trained to handle hazardous materials and that equipment is readily available to handle emergencies. Failure to secure access to unauthorized areas in the facility and have properly trained staff has the potential to affect all patients and staff who receive care/administer care in this area.

Findings by Surveyor #26711 include:

OB
The following was observed during a tour of the OB unit which was conducted on 1/24/2012 at 9:25 a.m. accompanied by Lead RN VV and CNO A:
In a room identified as "Soiled Utility" a bottle of Aseptizyme (chemical cleaner) was sitting out on the counter by the sink. The door to the room was unlocked to the corridor which could allow access for any unauthorized persons (patients, visitors) and has the potential to cause injury. This room is not visible to staff at all times.

This finding was confirmed at the time of discovery by CNO A.


13469

Findings by surveyor #13469:

Surgical staff are not trained for the unusual occurrence or incident related to the handling of the hazardous material Formalin to protect staff and patients from adverse reactions to exposure.

Per review of hospital P/P Hazardous Materials Program effective date 8/08 reviewed on 1/26/12 in the AM, directs the following: "1.0 Education and Training of Employee: Employees who may be exposed to hazardous chemicals or materials when working will be provided with information and trailing. 1. Department specific education of staff will be provided during department specific orientation, annually through the HelathStream on-line Learning Center, and at any time a new chemical is introduced in the work area.

Per interview, with with OR Manager (P) and RN, RC (B) on 1/24/12 at 10:00 AM and RN, RC (B) on 1/25/12 at 1:50 PM , it was revealed that there is no evidence that surgery staff have been trained to the safe clean-up of hazardous chemical Formalin should there be a spill in the OR. Per interview, with RN,RC (B) on 1/25/12 at 8:45 AM, the OR department uses the following sizes of containers of Formalin: 360 ml (milliliters), 240 ml and 60 ml.

Per observation and interview while touring the GI (Gastrointestinal Lab) on 1/25/12 at 2:30 PM with RN (FFF) and RN,RC (B), the crash cart in the GI lab unit did not contain back-up laryngoscope bulbs readily accessible should there be a failure of a bulb during intubation. Per (B), all the crash carts in the hospital are set-up the same and would not contain back-up laryngoscope bulbs.

Per interview and observation, while touring the OR department with OR Manager (P) and RN,RC (B) on 1/24/12 at 8:25 AM, it was noted that there are several entrances and exits leading into and out of the OR department that are not secured when the surgery department is closed. Per (B) and (F) the OR has an "exit hallway" going through the departments and therefore cannot be locked. Per (F), the medication room is locked with the suture cart at the end of the day, but the rest of the OR is not secure from unauthorized assess, tampering, removal and destruction of OR equipment. Review of the department with Life Safety Code surveyor #18107 it was revealed that all seven of the OR suites and multiple supply rooms could be secured at the end of the day with locking devices.


26390

Findings by Surveyor #26390:

On 1-23-2012 at 3:40 PM a tour of the ICU (Intensive Care Unit) was completed with RN B, CNO A, and QM I. The clean supply closet was observed to be unlocked and 2 bottles of all purpose cleaner were unsecured, on the counter. RN B, CNO A, and QM I observed the same.

On 1-24-2012 at 8:12 AM a tour of Respiratory Therapies storage areas was completed with J, Dir. Of Pharmacy & Respiratory Care (DPRC), and Quality Manager (QM) I. Dirty storage room #333 was observed to be unlocked with unsecured cleaning supplies on the counter (1 bottle of QUAT and 1 bottle of Tor) Both DPRC, J and QM I observed the same.

Based on observations, P/P review, staff interviews, and standards of practice, the hospital failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases, in 6 of 9 departments observed (Emergency Department-ED, Obstetric unit-OB, Medical/Surgical unit-Med/Surg, Surgical suite, Out-patient surgery, and Kitchen). This affected all current hospital patients.

Findings include:

This condition is NOT MET as evidenced by:

The facility failed to maintain a sanitary environment in patient care departments, failed to have a system for assessing and monitoring environmental sanitation, and failed to follow standards of practice for medication safety and food preparation. See A0749

These cumulative failures resulted in an inability to ensure that the hospital maintained a sanitary environment that identified, prevented and/or controlled sources of potential infections for all patients.

Based on observations, P/P review, nationally accepted standards of practice, and staff interviews the hospital failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases, in 7 of 10 departments observed (Emergency Department-ED, Obstetric unit-OB, Medical/Surgical unit-Med/Surg, the Surgical suite, Environmental Services, outpatient surgery area and Kitchen).

The facility also failed to include a system of appropriate monitoring of medication safety, housekeeping and sterile processing to ensure that the hospital maintains a safe and sanitary environment. Failure to maintain a sanitary environment in the facility had the potential to affect 36 inpatients and 7 outpatient surgicals on 1/23/2012, 36 inpatients and 6 outpatient surgicals on 1/24/2012, 37 inpatients and 5 outpatient surgicals on 1/25/2012, and 29 inpatients and 10 outpatient surgicals on 1/26/2012.

Findings by Surveyor #26711 include:

According to the Centers for Disease Control (CDC), who publish nationally recognized standards of practice and recommendations for health care organizations, the following recommendations regarding handwashing/glove changing were published in the October 2002 Morbidity and Mortality Weekly Report (MMWR): 1. Decontaminate hands before having direct contact with patients, 2. Decontaminate hands after contact with a patient's intact skin (e.g., when taking a pulse or blood pressure, and lifting a patient), 3. Decontaminate hands after contact with body fluids or excretions, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled, 4. Decontaminate hands if moving from a contaminated-body site to a clean-body site during patient care, 5. Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient, 6. Decontaminate hands after removing gloves.

Occupational Safety and Health Administration Bloodborne Pathogen standards at 29 CFR 1910.1030(d)(3)(ix) requires the following: " Gloves. Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, and non-intact skin; when performing vascular access procedures except as specified in paragraph (d)(3)(ix)(D); and when handling or touching contaminated items or surfaces. "

Per Surveyor #13569 review of P/P Infection Prevention - Hand Hygiene effective date 7/2011, on 1/26/2012 in the AM, the hand washing policy directs the following: "Special Instructions: 3. If hands are not visibly soiled, health care workers may either use an alcohol-based hand rub or wash hands (as in #2 with soap and water) in all other clinical situations listed below: a. upon entering patient's room and prior to patient contact. b. before an aseptic task. c. before donning gloves prior to invasive procedures. d. after contact with a patients intact skin. e. after contact with body fluids, excretions, mucous membranes, non-intact skin, or wound dressings as long as hands are not visibly soiled. f. if moving from a contaminated body site to a clean body site during patient care. g. after contact with inanimate objects in the immediate vicinity of the patient. h. after glove removal."

In an interview with IP RN V on 1/25/2012 at 10:30 a.m., with CNO A and VP UU present, IP RN V acknowledged that Tide (laundry soap) is being used for mop heads in the housekeeping department and that this product was changed without notifying the facility IP. IP RN V stated this product is not approved by the IP committee.

ED
The following are findings observed during a tour of the ED which was conducted on 1/24/2012 at 8:05 a.m. accompanied by Mgr. WW and CNO A:
In a room indicated as a clean supply room, dietary supplies were also being stored. On shelves above the sink there were bottles of Computerized Tomography (CT) contrast (medical dye used for diagnostic purposes) stored next to packaged food (crackers) and packaged drink powder (Crystal light).
On an adjacent shelf there were sterile packs of supplies (suture kits and other sterile items) stored next to packaged food items. This practice does not reflect the separation of clean and dirty.

In a room identified as the Ear, Nose, and Throat room, the laminate covering on the cabinet was broken and chipped making an non-smooth surface and therefore affecting the ability to effectively disinfect this area.

These findings were confirmed at the time of discovery by Mgr. WW and CNO A.

OB
The following are findings observed during a tour of the OB unit which was conducted on 1/24/2012 at 9:25 a.m. accompanied by Lead RN VV and CNO A:
The linen room walls had several areas of missing paint and gouges in the dry wall making this a non-smooth surface and difficult to effectively clean.
In a room identified as the "Classroom," which is currently being used as a storage room, it was identified that dirty/used equipment was being held until it could be cleaned. This room also contained clean supplies and equipment and literature materials for teaching purposes to new mom's. An open doorway into this room revealed a room where the Pyxis (computerized medication dispenser) machine was stationed, and another open doorway from the room where the Pyxis machine was kept was open to the nursing station. This does not demonstrate a separation of clean and dirty.

These findings were confirmed at the time of interview and discovery by CNO A and Lead RN VV.

Outpatient
An observation of a blood draw with Phlebotomist (Phleb) Z was conducted on 1/25/2012 at 11:30 a.m. accompanied by CNO A. The following observations were made:
Phleb. Z put the tourniquet to be used on Pt. #36 over Z's shoulder when preparing the vacutainers and needle set for the blood draw.
With gloved hands handled cart with supplies, reached into tray with clean supplies several times to obtain equipment needed, obtained a blood sample and discarded the needle and trash, documented with pen from pocket, applied a gauze dressing to the puncture site.
All these tasks were completed with the same pair of gloves on.
When interviewed regarding the use of gloves and if Z ever changes gloves after the venipuncture and discarding of supplies but before documenting or putting on a clean dressing, Phleb. Z replied, "Nope, one pair of gloves per patient, I've always done it that way."

These finding were confirmed with CNO A at 11:50 a.m. on 1/25/2012.


26390

Findings by Surveyor #26390:

Med/Surg
On 1-24-2012 at 9:35 AM CNA (certified nursing assistant) XX, was observed by Quality Manager (QM) I and Surveyor #26390. CNA XX completed bathing cares with pt. #34. CNA XX set up supplies for bathing on the Pt's bedside table without removing the Pt's personal items. After washing pt. #34's groin area CNA XX removed gloves and left the room without washing hands or using hand gel. Upon return CNA XX put on a new pair of gloves without cleaning hands, and completed peri care. When finished washing pt. 34, CNA XX placed the soiled wash cloth on the bedside table next to the pt's water carafe, open apple juice and banana. CNA XX removed gloves and did not wash hands. After CNA XX cleaned up supplies the bedside table had bath water on top. CNA XX did not clean off the bedside table after bathing care.

These findings were confirmed by QM I at the time of the observation.

On 1-24-2012 at 10:31 AM RRT K was observed by Surveyor #26390 and IP RN V during a breathing treatment for pt. #35. RRT K auscultated pt. #35's lungs with A stethoscope, making contact with pt's skin, and used hand gel to clean stethoscope. The treatment was finished and RRT K auscultated pt. #35's lungs, again making contact with pt. #35's skin and followed by using hand gel on the stethoscope to clean it.

IP V, observed the same and informed RRT K, it was not the hospital's P/P to use hand gel for cleaning stethoscopes.

On 1-26-2012 at 10:55 AM a review of the hospital P/P titled "Disinfection, Sterilization and Shelf Life" was completed. Page 2, section III. titled Non-Critical Items states in part, the following, "Items which come in contact with skin but not with mucous membranes. Items in this category can be cleaned with a low level disinfectant. Isopropyl alcohol (70-90%), sodium hypochlorite (1:500 dilution), iodophor germicidal detergent solution, quaternary ammonium or phenolic germicidal detergent solution will be used to disinfect these items."

On 1-26-2012 at 11:30 AM a review of the manufacturer's label for the hand gel used by the hospital was completed. The active ingredient in the Endure 320 by Eco Lab is Ethyl Alcohol 62%.


13469

Examples per surveyor #13569:

Surgery
1. Medication vials/multiple dose vials and intravenous tubing are not accessed per standards of practice and hospital P&P allowing for the possible transfer of microorganisms to patient #28 on the day of his surgery on 1/24/12.

Per APIC (association for professionals in infection control and epidemiology) position paper 2010 "Safe Injection Practices" directs the following: "keep multi-dose vials away from the immediate patient environment" if the multiple dose vial is used for more than one patient.

CDC guidelines for safe injection practices:
IV.H.7. Do not keep multidose vials in the immediate patient treatment area and store in accordance with the manufacturer's recommendations; discard if sterility is compromised or questionable 453, 1003. Category IA
Per review, of hospital P&P Medication Administration effective date April 2011 on 1/26/12 in the AM, the policy directs the following: "E. Medications are not to be opened until the caregiver is at the patient's bedside except in the following circumstances: 1. Multidose vials."

Per hospital P/P Parenteral admixture quality control program effect date August 2010, the P&P directs the following: "IV. b. iv. The tops of all vials and injection ports of bags and bottles are to be swabbed with alcohol before entering with a needle."

Per observation, during the preparation of surgery for patient #28 on 1/24/12 at 8:25 AM with OR Manager (P) and RN, RC (B), Anesthesiologist (R) prepared medications to be used for anesthesia. Dexamethazone was drawn from a multiple-dose vial and the unused portion of the vial was placed back into the anesthesia cart. Propofol was then drawn up into a syringe and the vial discarded into a waste basket. Anesthesiologist (R) failed to clean the septum of the vials prior to access with the syringes. Per interview with (R) at the time of the observation the unused portion of the Dexamethazone placed back into the anesthesia cart was intended for use for subsequent patients. During this same observation, (R) accessed patient #28 intravenous tubing to administer the Dexamethazone without the benefit of cleaning the port with alcohol prior to administering the drug.

After Pt. #28 had left the OR suite, and during the time staff were cleaning up the room and setting up for the next case CRNA (S) entered the room and proceeded to draw up medications for the next case. CRNA drew up Propofol, Versed and Zofran in succession. CRNA (S) failed to clean the septum of the vials prior to access with the syringes

The above examples were confirmed in interview with Manager (P) and RN, RC (B), following the observations on 1/24/12.

2. Equipment that falls on the floor and is potentially contaminated with microorganisms is not cleaned before reuse on patients.

Per observation, during the preparation of surgery for patient #28 on 1/24/12 at 8:50 AM with OR Manager (P) and RN, RC (B), Anesthesiologist (R) dropped a blood pressure cuff on the floor, picked it up and placed it on Pt. #28 arm without the benefit of cleaning it using a low-level disinfectant prior to placing it on Pt. #28 arm. This example was confirmed in interview by (B) and (P) following the observation.

3. Staff are not following hand hygiene P/P and standards of practice.

Per observation, during the preparation of surgery for patient #28 on 1/24/12 between 8:50 AM and 9:20 AM with OR Manager (P) and RN, RC (B), Anesthesiologist (R) applied gloves and removed gloves three times without the benefit of washing his hands before and after glove changes. The above examples were confirmed in interview with Manager (P) and RN, RC (B), following the observations on 1/24/12.

4. The OR P&P for using the alcohol-based Avagard surgical hand rub is incomplete.

Per interview with OR Manager (P) and RN, RC (B) and Surgeon (Q) on 1/24/12 at 10:55 AM, it was determined that the surgical hand antisepsis P&P and practices do not include what surgical staff are to do if they leave the OR between cases and return using the alcohol-based Avagard surgical hand rub. Policy review on 1/30/12 revealed that this is not addressed. As a result, staff could be exposed to microorganisms with a general risk for contamination when out of the OR.

In addition, the hospital P&P do not include directions for the Avagard product use. This was confirmed in interview with RN/RC (B) on 1/25/12 at 8:50 AM.

5. Doorways leading into clean supply rooms located in the OR are propped open allowing for cross-contamination, dust, and debris

Per observation, while touring the surgery department on 1/24/12 between 10:30 AM and 11:20 AM with OR Manager (P) and RN, RC (B), it was noted that doorways leading into clean supply rooms and the door leading into the instrument processing and sterilization room were propped open. As a result, the air exchange into the rooms is disrupted allowing for possible contaminants, dust and debris to enter the rooms and settle on sterile packs and clean equipment. (P) and (B) confirmed the observation in interview during the tour.

6. Cleaning and disinfection of surgical instruments is not following standards of practice and manufacturers directions.

Per CDC (centers for disease control and prevention) guidelines for disinfection and sterilization in healthcare facilities, 2008 it recommends the following: Use appropriate EPA (environmental protection agency) registered cleaning agents that are capable of removing visible organic and inorganic residues following manufacturers directions. In addition, the CDC recommends that cleaning brushes used for the removal of organic residue be disposable or thoroughly cleaned and either high-level disinfected or sterilized after each use.

Per interview and observation, on 1/24/12 at 11:05 with SPD Technician (L) , the enzymatic cleaning solution used to remove bioburden from surgical instruments prior to sterilization is not measured to ensure the proper concentration of the water and enzymatic cleaner. A large tub contained the solution of water and cleaner. Per (L), the manufacturer directs a concentration of 1 ounce of enzymatic cleaner to 1 gallon of water. Per (L) the container currently has 5 ounces of cleaner to 5 gallons of water. When asked how they know how much water is 5 gallons (L) said they eye-ball it. In addition, (L) revealed that the enzymatic cleaning solution are not changed between each case to prevent microbial growth.

Per observation, during the tour, it was noted that a small steel tray held 5 various types of brushes used to manually remove visible organic residue from surgical instruments. Per SPD Technician (L), it was revealed that the brushes are used for the entire day and then run through a washer-disinfection machine. Per (L), the cleaning brushes are not disposable, high-level disinfected or sterilized after each use.

Environmental Services
1. Privacy curtains are not cleaned per hospital P/P allowing for the possible transfer of microorganisms to patients, visitors and staff.

Per review, of hospital P/P Cubicle Curtains effective date March 13, 2009 on 1/26/12 in the AM, the P&P directs the following: 1. Cubicle curtains will be inspected at the time of patient discharge/transfer for soiling or damage. If no visible soiling is found the curtain is sprayed with the hospital approved disinfectant 24 inches back from the edge. 2. If the curtains become visibly soiled with body fluids or are damaged, the curtain is replaced. 3. All cubicle curtains in the ED, GI Lab and Surgery/PACU will be replaced and laundered quarterly. All other curtains will be replaced and laundered semi-annually." A template schedule log is attached to the P&P.

Per interview, with Linen Services employee (N) and EVS Manager (O) on 1/24/12 at 1:05 PM, it was determined that privacy curtains are not on a routine cleaning schedule. Both (N) and (O) were unable to validate where all the privacy curtains are in the facility and did not have a log of when they were last cleaned. Per EVS Manager (O), he thought the facility was changing them about one time per year. Per (O), the surgery department handles their own privacy curtains.

Per interview with RN, RC (B) on 1/25/12 at 8:05 AM, the surgery department does not manage their own privacy curtains. There is no log and no way of knowing when they were last replaced. Per (B), the hospital is not following the hospital P&P for the cleaning of privacy curtains.

2. Detergents used for laundry have not been authorized for use in the hospital by the infection control committee to ensure appropriate disinfection.

Per interview, with Linen Services employee (N) and EVS Manager (O) on 1/24/12 at 1:05 PM, it was determined that Tide Ultra is being used to launder the flat mops for the cleaning of the floors throughout the hospital. Per interview with EVS Manager (O) on 1/25/12 at 11:15 AM, the hospital cannot prove that Tide is approved by the EPA (environmental protection agency) for use in healthcare facilities to ensure appropriate disinfection. Per (O) and (N), this product has not been approved for use in the hospital by the infection control committee.

3. Cleaning and disinfecting products used to do environmental cleaning are not checked for appropriate concentrations per manufacturers directions.

Per interview, with EVS Manager (O) on 1/24/12 at 1:05 PM, it was noted that housekeeping staff are not doing quality control checks on the automated dispensing systems used for the environmental cleaning products used throughout the facility. Per interview, with (O) on 1/25/12 at 11:15 AM, (O) said after contacting the manufacturer it was found that a test strip should be used each time the bottles are changed to ensure that the concentrations are correct to ensure appropriate disinfection of surfaces.

4. Sharps containers are not always accessible or replaceable by nursing and medical staff.

Occupational Safety and Health Administration Bloodborne Pathogen standards at 29 CFR 1910.1030 for Contaminated Sharps "Discarding and Containment: 1910.1030(d)(4)(iii)(A)(1) Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are: 1910.1030(d)(4)(iii) (A)(2)(i) easily accessible to personnel and located as close as it feasible to the immediate area where sharps are used or can be reasonably anticipated to be found. and 1910.1030(d)(4)(iii)(A)(2)(iii) replaced routinely and not be allowed to over fill."

Per interview, with EVS Manager (O) on 1/24/12 at 1:05 PM, it was revealed that the biohazard waste pick-up process for sharps containers it done by a contracted service. The contracted service comes into the facility every two weeks and goes around to all the locations with sharps containers and replaces the ones that are full to the fill line. When asked how they are replaced if they become full between the pick up every two weeks (O) said he is the only one who is allowed to replace the full containers. Per (O) he is not however in the facility 24/7. When asked what staff are to do if he is not in the building (O) said that staff can go above the fill line of the containers or go in search of another container to discard contained sharps until he can change the container. As a result, staff are being encouraged to practice against standards of practice by overfilling sharps containers and carry contaminated/sharp needles, razors, blades etc. in search of a disposal site.

Per interview with RN/RC (B) on 1/25/12 in the afternoon, there is no P&P for the handling and replacement of sharps containers.

6. Foods are not perpared and served under sanitary conditions:

Findings by Surveyor #29302 include:

On 1/24/2012, 10:07 a.m. to 10:17 a.m., surveyor 29302 observed dietary assistant (D.A.) AAA working on the dirty side of the dish machine, then going to work on the clean side of the dish machine without washing hands between tasks. D.A. AAA was unloading dirty dishes from a food cart and placing the dirty dishes onto dish racks. D.A. AAA would push racks with dirty dishes into the dish machine. After the wash and rinse cycle of dish machine was completed, D.A. AAA would go to the clean side of dish machine, pull out the racks of clean dishes/equipment, then would put dishes/equipment away. D.A. AAA did not wash hands between these tasks.

On 1/24/2012, 3:30 p.m. - 4:00 p.m., surveyor 29302 reviewed facility's HACCP[Hazard Analysis and Critical Control Points]/Food Safety Program which states, "Hands must be washed frequently and correctly - after handling dirty equipment."

In an interview with D.A. AAA on 1/24/2012, 10:07 a.m.-10:17 a.m., surveyor 29302 asked D.A. AAA how often the wash and rinse temperature gauges are checked which are located on the outside of the hot water sanitizing dish machine. D.A. AAA stated, "Every shift."

On 1/24/2012, 3:30 p.m. - 4:00 p.m., surveyor 29302's review of the facility's "DISHWASHING/WAREWASHING MACHINE TEMPERATURE LOG," revealed that temperatures were missing for the following dates in January 2012: 01/02- dinner, 01/03-breakfast and lunch; 01/04-breakfast, lunch and dinner, 01/05 - dinner, 01/06-breakfast and lunch, 01/07-dinner, 01/08-dinner, 01/09-lunch, 01/10-breakfast and lunch, 01/11-breakfast and lunch, 01/13- breakfast and lunch, 1/16-breakfast, lunch and dinner, 1/17-breakfast and lunch, 1/21-dinner, 1/22-dinner, 1/23-breakfast, lunch and dinner.

On 1/24/2012, 3:30 p.m.-4:00 p.m. surveyor 29302 reviewed facility's tool, "Food Safety Audit," which has an area that states "Dishwashing/Warewashing Machine Temperature Log completed for each meal period" which was shown to and verified by F.C. ZZ.

On 1/24/2012, 10:07 a.m.-10:17 a.m., surveyor 29302 asked D.A. AAA how often is the internal temperature of the hot water sanitizing machine is checked? D.A. AAA stated that AAA does not check the internal temperature.

Surveyor 29302 interviewed F.C. ZZ on 1/24/2012 at 3:00 p.m. and ZZ reported the facility does not do a daily check of the internal temperature of the machine and ZZ has never been in a facility that does that. F.C. ZZ. stated, "There are no records available."

Surveyor 29302 reviewed facility's tool " Food Safety Audit " which does have an area that checks for "method for validating the final rinse of manual stations and the dishwashing cycle (chemical test strips, thermal strips and registering thermometer)."

The 2009 Food and Drug Administration (FDA) Food Code states that food shall be protected from contamination by storing the food at least 6 inches above floor.

On 1/24/2012, 10:28 a.m., surveyor 29302 toured the dry food storage area, accompanied by F.C. ZZ, and made the following observations of items stored directly on the floor:
· Case of cream of chicken soup
· Bottle of Dasani Water
· Full case of VitaminWater®
· Partial case of VitaminWater®
· Gatorade product G2
· Cases of Pepsi
· Cases of Mountain Dew
· Single bag of potato chips

The 2009 FDA Food Code states that nonfood-contact surfaces of equipment shall be cleaned at a frequency necessary to preclude accumulation of soil residues.

On 1/24/2012, 10:45 a.m., surveyor 29302 ran fingers of right hand along edge of oven hood leaving fingers very dirty and greasy. F.C. ZZ ran ZZ's fingers along the edge of oven hood at the other end of stove stating ZZ's fingers were dusty.

On 1/24/2012, 3:30 p.m. - 4:00 p.m., surveyor 29302's review of facility's "Food Safety Audit" states "All non-food contact surfaces (including cooking equipment, cold storage units, preparation equipment/surfaces, service counters, etc.) clean."

According to the 2009 FDA Food Code, single-use gloves are to be used for only one task and discarded when damaged or soiled, or when interruptions occur in the operation. Hands are to be washed before engaging in food preparation including working with exposed food, clean equipment and utensils and
· After handling soiled equipment or utensils
· After coughing or sneezing
· After engaging in other activities that contaminate the hands.

On 1/24/2012, 11:28 a.m.-11:37 a.m., surveyor 29302 observed Chef BBB take temperatures of food items in the steam table. During this time, surveyor 29302 observed Chef BBB drop a wrapper from an alcohol wipe, pick it up from the floor and then proceed to take the temperatures without washing hands.

Surveyor 29302 then observed Chef BBB to cough into BBB's left elbow, then into BBB's right hand; without washing hands. Chef BBB then proceeded to take temperatures of food items in steam table.

On 1/24/2012, 11:38 a.m., surveyor 29302 observed Chef BBB drop a used alcohol wipe into a sink. Chef BBB then reached into sink, pulled out dirty alcohol wipe, set it onto a stainless steel counter top, then proceeded to finish taking the temperatures of food items in steam table without washing hands.

On 1/24/2012, 11:52 a.m., surveyor 29302 observed D.A. EEE wearing disposable gloves, drop the handle of tongs onto buttered noodles while working on tray line. D.A. EEE picked up tongs - did not remove noodles that were potentially contaminated by handle of tongs, did not remove gloves and wash hands and continued to use same tongs to serve the remainder of the noodles.

On 1/24/2012, 11:53 a.m., surveyor 29302 observed D.A.CCC, with disposable gloves on, leave tray line and walk over to a desk. With gloves still on, D.A.CCC spoke on the phone and worked on some paperwork. At 12:00 p.m., surveyor 29302 observed D.A.CCC return to tray line with same gloves on and continue to work on tray line, placing flatware and fruit cups onto patient's trays.

On 1/24/2012, 11:58 a.m., surveyor 29302 observed D.A. EEE, wearing disposable gloves, leave the tray line. At 11:59 a.m., D.A. EEE, without washing hands, returned to tray line and proceed to dish up soup. At 12:02 p.m., D.A. EEE, wearing the same disposable gloves, left the tray line, returning at 12:03 p.m. with extra buttered noodles. At 12:05 p.m., surveyor 29302 asked D.A. EEE. if EEE washed EEE's hands anytime the tray line was left, which D.A. EEE responded, "No."

According to the 2009 FDA Food Code, food employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food, clean equipment, utensils, and linens; and unwrapped single-service and single-use articles.

On 1/24/2012, 10:04 a.m., in the kitchen, surveyor 29302 observed Chef DDD's mustache not covered.

On 1/24/2012, in the kitchen and during the following times, 10:03 a.m. through 10:52 a.m. and 11:28 a.m. through 12:05 p.m., surveyor 29302 observed F.C. ZZ's facial hair uncovered.

On 1/24/2012, 3:15 p.m. - 3:30 p.m., surveyor 29302's review of facility's HACCP/Food Safety Programs, Company Standards/Guidelines for hair restraints revealed it does not reflect current professional standard of practice which is the 2009 FDA Food Code.

The 2009 FDA Food Code, states "FOOD EMPLOYEES shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS; and unwrapped SINGLE-SERVICE and SINGLE-USE ARTICLES. Company Standards/Guidelines: "Hair restraints (hairnets, hats or coaps) must cover hair sufficiently to prevent hair from falling onto food or food equipment and to minimize hand contact with hair. (company standards/guidelines does not address facial or body hair).

According to the 2009 FDA Food Code, a handwashing sink or group of adjacent handwashing sinks that is provided with disposable towels shall be provided with a waste receptacle.

On 1/24/2012, 10:03 a.m., surveyor 29302 washed hands at sink located inside doorway off the hallway. No waste receptacle was available near sink as verified by F.C.ZZ.

On 1/24/2012, 10:45 a.m., surveyor 29302 washed hands after getting them dirty from oven hood. Handwashing sink is located near stove/oven and did not have a waste receptable available which was verified by F.C. ZZ.

On 1/24/2012, 10:46 a.m., surveyor 29302 observed a large square green plastic bin being used as a waste receptacle next to handwashing sink located near desk. According to the 2009 FDA Food Code, a waste receptacle must have the means to be kept covered which this bin did not have.

On 1/24/2012, during tours of kitchen, 10:03 a.m.through 10:52 a.m. and 11:28 a.m. through 12:06 p.m., F.C. ZZ was present with surveyor 29302 while in ktichen and verified all findings.

Based on 7 of 12 MR reviewed, P&P review, 1 of 1 observations, 3 of 3 credential files reviewed, and 7 of 7 interviews with facility staff, the hospital failed to ensure that surgical services are provided in accordance with acceptable standards of practice and hospital P&P. This affected all current hospital patients.

Findings include:


On 1/26/12 at 8:30 AM CEO (AA) was notified by surveyor #13469 that an Immediate Jeopardy was identified at 3:00 PM on 1/25/12 because FAs were performing surgical tasks without proper privileges. Immediate jeopardy was removed at 4:30 PM on 1/25/12 as a result of actions taken to immediately remove the FAs from surgical rotations and assigning all scheduled surgeries to credentialed and privileged surgeons. The hospital failed to ensure that surgical physician assistants (RN, PA, NP, technicians) are granted surgical privileges and that the surgical services department maintain a current roster of practitioners specifying the surgical privileges of each practitioner prior to their actual surgical practices. See A945.

At 12:00 PM on 1/26/12 surveyor #13469 was presented copies of letters notifying the entire medical staff, that all 16 FA's and their supervising surgeons, were pulled from upcoming surgery schedules until all credentialing processes are completed.

The hospital failed to ensure that surgical patients are protected from fire. The hospital failed to use a surgical skin scrub per manufacturers directions for patient #28. See tag A-951

The hospital failed to ensure that the patient/representative be informed of, and consent to the identity of the First Assists who participate in their surgery, and the tasks they will perform. See Tag A-955

The cumulative effect of these systemic surgical service practices resulted in the facility's inability to ensure that surgery patients are afforded their patients rights to be fully informed, and receive safe and optimal patient care.

Based on 3 of 12 MR reviewed of surgical patients (Pt. #12, 29, and 33 ) out of a total of 33 MR reviewed, 7 of 7 staff interviews (P, B, AA, Q, CC, DD, and BB), 3 of 3 first assist credential files reviewed (EE, FF, and GG), and review of the Medical Staff Rules and Regulations, the hospital failed to ensure that physician's surgical assistants (RN, PA, NP, technicians) are granted surgical privileges and that the surgical services department maintain a current roster of practitioners specifying the surgical privileges of each practitioner. This affected 1 patient who had a surgical First Assist on Monday 1/23/12, and 1 patient who had a First Assist (FA) on Wednesday 1/25/12.

Findings include:
Examples by surveyor #13469:

The Medical Staff Rules and Regulations, dated 9/22/2011, were reviewed on 1/24/2012 at 7:30 a.m. by Surveyor #26711. On page 2, #6 states in part, "A Medical Staff appointee or Allied Health Professional with clinical privileges and appropriate staff status per the Medical Staff Bylaws and Credentialing Policies shall be responsible for the medical care and treatment of each patient in the hospital..."

Per interview, with OR Manager (P) and RN/RC (B) on 1/24/12 at 10:00 AM, when asked if the hospital used any FA two physician FA were identified during the interview, FA (JJ) and (RR). (P) could not produce a list of the FA working in her department.

Review of (JJ) and (RR) files revealed that they have not gone through the established criteria, qualifications and credentialing process to be granted specific privileges to be performed as a FA. This was validated in interview with (P) and (B) at 9:00 AM.

Per interview, with OR Manager (P) and RN/RC (B) on 1/25/12 at 8:45 AM it was revealed that FA (JJ) and (RR) manipulate tissue and close per OR RN (YY) and (T).

When OR Manager (P) was asked on 1/25/12 in the AM if there were anymore FA working in the surgery department at 9:00 AM three more FA were identified: FA (GG), (FF), and (EE).

At 9:15 AM on 1/25/12 the hospital CEO (AA) was notified by surveyor #13469, OR Manager (P) and RN/RC (B) there are currently two FA working in surgery, manipulating tissue who are not credentialed and privileged (JJ and RR). Per (AA), he was not aware of this.

On 1/26/12 at 8:30 AM CEO (AA) was notified by surveyor #13469 that an Immediate Jeopardy was identified at 3:00 PM on 1/25/12 due to the fact that FAs were working in surgery, whom were not hospital employees, and were not priviliged by the hospital. Immediate jeopardy was removed at 4:30 PM on 1/25/12 as a result of immedate extraction of all uncredentialed FAs from surgical rotations.

At 7:15 AM on 1/26/12 CEO (AA) revealed to surveyor #13469 that the COS and surgeons scheduled to perform surgery on 1/26/12 and 1/27/12 met and cleared all FA from the surgery schedules and were replaced with other surgeons. Only two dental surgeries scheduled for Friday 1/27/12 may have to be rescheduled.

At 12:00 PM on 1/26/12 surveyor #13469 was presented copies of letters notifying the entire medical staff, all 16 FA's and their supervising surgeons, that the 16 FA's were being pulled from upcoming surgery schedules until they have gone through the credentialing process and have been granted temporary privileges.

After review of the surgery schedule for 1/25/12 it was determined that FA (JJ) was currently in surgery with a patient who was having wide excision right hip lesion. In addition, (FF) was scheduled for two more surgeries on 1/25/12.

At 9:50 AM on 1/25/12 COS (Q) was informed by surveyor #13469, CEO (AA), OR Manager (P) and RN/RC (B) that two FA (JJ and RR) were not credentialed and privileged to work in the hospitals OR and that FA (JJ) was currently in surgery. Per COS (Q), he was not aware of this. It was decided to immediately notify the surgeon on the case to cease to allow FA (JJ) from doing any manipulation of tissue and to allow only the passing of instruments until the case was completed.

The Surgeon, Surgery Medical Director (BB) and FA (JJ) were notified per letter signed by all parties between 12:18 and 1:30 PM that the final two cases of the day would not be completed utilizing FA (JJ). The remaining two cases that were to utilize FA (JJ) were covered by other surgeons in that role.

At 3:00 PM RN/CR (B) revealed that there are many FA currently working in the surgery department who are not privileged. A request was made for a full list of all FA being utilized in the surgery department and currently going under the credentialing process along with the dates the FA first began work in the hospitals surgery department.

Review of Thursday 1/26/12 and Friday 1/27/12 surgery schedules at 3:30 PM revealed that there were 5 cases each day utilizing FA.

At 3:30 PM a full list of FA was presented to surveyor #13469 totaling 17, one of whom had not started work yet. Review of the three credentialed FA revealed that 3 of 3 were not privileged appropriately. FA (EE) was credentialed and privileged on 7/31/09. Current privileges dated 4/7/11 do not include surgery FA duties. FA (GG) and (FF) privileged in March of 2011 indicate they can perform duties of a "surgical first assist." The privilege list does not include what those duties entail.

After determining that 16 of 16 FA (HH who started on 1/16/03, II who started on 10/28/02, JJ who started on 7/30/01, KK who started on 10/24/02, LL who started on 6/90, MM who started on 4/22/99, NN who started on 2/8/07, OO who started in 1979, PP who started on 4/17/03, QQ who started on 10/23/97, RR who started on 3/21/11, SS who started on 4/21/05, TT who started on 11/19/09, EE who started on 7/31/09, FF who started on 3/14/11 and GG who started on 3/15/11) working the hospital surgery department were not fully privileged the hospital CEO (AA) notified COS (Q) and the Surgery Medical Director (BB) of the situation and the decision was made to pull all 16 from upcoming surgery schedules and grant temporary clinical privileges per medical staff rules and regulations once the FA had gone through the credentialing process until the governing body could provide the final signatures.

Based on 1 of 1 observations, 7 of 12 surgery patient MR reviews (Pt. #12, 19, 22, 28, 29, 30, and 32) out of a total of 33 MR reviewed, P&P review, and 3 of 3 staff interviews, the hospital failed to ensure that surgical patients are protected from fire. The hospital failed to use a surgical skin scrub per manufactureres directions for patient #28.

Findings include:
Examples per surveyor #13469:

1. The Association for Operating Room Nurses (AORN) Perioperative Standards and Recommendations, 2008 Edition indicate:
IX.d.1. Waterless, brushless, surgical-scrub solutions should be allowed to dry completely to decrease the potential to produce ignition by static electricity or sparks.
IX.d.3. Provide adequate time for the flammable surgical prep solution to dry completely and any fumes to dissipate before applying surgical drapes, using an active electrode or laser, or activating a fiber-optic light cable.
IX.d.5. Drapes should not be applied until prep solutions are dry, to prevent the accumulation of volatile fumes beneath them.

Per operating room policy and procedure review, on 1/24/2012 in the afternoon, the operating room policies do not include a policy to reduce the risks of fires due to the use of alcohol-based skin preparations in anesthetizing locations including:

A Using skin prep solutions that are 1) packaged to ensure controlled delivery to the patient in unit dose applicators, swabs or other similar applicators: and 2) provide clear and explicit manufacturer/supplier instructions and warnings. These instructions for use should be carefully followed.

B Ensuring that the alcohol-based skin prep solution does not soak into the patient's hair or linens. Sterile towels should be placed to absorb drips and runs during application and should then be removed from the anesthetizing location prior to draping the patient.

C Ensuring that the alcohol-based skin prep solution is completely dry prior to draping. This may take a few minutes or more, depending on the amount and location of the solution. The prepped area should be inspected to confirm it is dry prior to draping.

D Verifying that all of the above has occurred prior to initiating the surgical procedure. This can be done, for example, as part of the standardized pre-operative " time out " used to verify other essential information to minimize the risk of medical errors during the procedure.

Per interview, with OR (operating room) Manager (P) on 1/24/2012 at 10:00 AM, she is not aware of these requirements.

Per interview, with OR Manager (P) on 1/24/2012 at 2:15 PM, the hospital operating room policies and procedures do not address the use of alcohol-based skin preparations in anesthetizing locations. The surgery department does use the following alcohol based skin preps: Dura prep, Chlorhexidine (hibiclens), Betadine scrub, betadine solution, and Chlora Prep.

Per interview, with OR manager (P) on 1/25/2012 at 8:45 AM, per RN (T) and RN (YY) operating nurses review the dry times of the skin preparations used at the initial orientation. In addition, it is reviewed along with the fire and safety inservices, as well as product representatives inservicing. However, there are no policies to reflect the products use and dry times for the skin preps used in the facility for surgical patients.

Per observation, of RN (T) on 1/25/12 at 9:05 AM, RN (T) applied the alcohol based skin prep Chlorhexdine (Hibiclens) to patient #28 genital area prior to a cystoscopy with biopsies.
Review of the product insert for Chlorhexidine gluconate (Hibiclens) was completed on 1/30/2012 in the AM; and the product insert cautions the user not to use it in the genital area for a scrub. Per interview, with OR Manager (P), RN, RC (B), and IP (V) per telephone on 1/31/2012 at 11:15 AM, Chlorhexidine gluconate (Hibiclens) should not be used in the genital area as a surgical scrub per manufacuturers directions. Per IP (V), the hospital is not using the product correctly.


26390

Findings by Surveyor #26390 include-

The facility's policy titled, "Medical Record Regulations," dated February 2011, was reviewed on 1/26/2012 at 10:00 a.m. by Surveyor #26711. On page 3, III. "Documentation-General Requirements," 3.1 b. states, "Entries shall be accurately written and represent the care/services provided."

On 1-24-2012 at 2:29 PM a review of pt. #12's record was completed with HIM Coord., U. The Operating Room Record shows on 11-14-2011 pt. #12 underwent a right total knee arthroplasty. The section titled, " Prep" had a check mark in the box next to "Chloraprep" . The section after "Dry" and between "Length" and "Min" was hand written, "per directions" . There is no documentation in the surgical record the prep was allowed to dry prior to draping.

On 1-25-2012 at 8:32 AM a review of pt. #19's record was completed with HIM Coord., U. The Operating Room Record shows on 11-14-2011 pt. #19 underwent a right total knee arthroplasty. The section titled, "Prep" had a check mark in the box next to "Chloraprep" and a hand written " x2 " next to it. The section after "Dry" between "Length" and "Min" was blank. There is no documentation in the surgical record the prep was allowed to dry prior to draping.

On 1-25-2012 at 11:37 AM a review of pt. #22's record was completed with Director of HIM, W. The Operating Room Record shows on 11-14-2011 pt. #22 underwent Irrigation and debridement of a lumbar spine wound. The section titled, "Prep" had a check mark in the box for Chloraprep. In the same section after "Dry" followed by "Length", a hand written 3 is present, followed by "Min." There is no documentation in the surgical record the prep was allowed to dry prior to draping.

These findings were confirmed at the time of the MR reviews with HIM Coord. U and Dir. W, and again on 1/26/2012 between 11:30-12:30 p.m. with RN B.


26711

Findings by Surveyor #26711:

A MR review was completed on Pt. #27's closed record on 1/25/2012 at 2:51 p.m. accompanied by HIM Coord. U. Pt. #27 had an Appendectomy on 11/11/2011 and Chloraprep (an alcohol based surgical skin preparation) was used. There is no documentation in the surgical record the preparation (prep) was allowed to dry prior to draping.

A MR review was completed on Pt. #28's closed record on 1/26/2012 at 8:04 a.m. accompanied by HIM Coord. U. Pt. #28 had bladder surgery on 1/24/2012 and Chlorhexidine (an alcohol based surgical skin preparation) was used.

Documentation indicates the preparation was allowed to dry for 5 minutes prior to draping. Per above documentation regarding the dry time for this surgery, Pt. #28 was draped directly after the preparation was applied. This discrepency was brought to the attention of HIM Coord. U at the time of the finding.

A MR review was completed on Pt. #29's closed record on 1/26/2012 at 8:27 a.m. accompanied by HIM Coord. U. Pt. #29 had a hernia repair on 11/2/2011 and the surgical skin prep was Chloraprep. There is no documentation in the surgical record the prep was allowed to dry prior to draping.

A MR review was completed on Pt. #30's closed record on 1/26/2012 at 8:47 a.m. accompanied by HIM Coord. U. Pt. #30 had surgery to repair a fractured hip. The surgical skin prep was Chloraprep. There is no documentation in the surgical record the prep was allowed to dry prior to draping.

A MR review was completed on Pt. #32's closed record on 1/26/2012 at 9:21 a.m. accompanied by HIM Coord. U. Pt. #32 had surgery to repair a fractured hip and the surgical skin prep was Chloraprep. There is no documentation in the surgical record the prep was allowed to dry prior to draping.

These findings were confirmed at the time of the MR reviews with HIM Coord. U, and again on 1/26/2012 from 12:15-12:30 p.m. with CNO A.

Based on 3 of 12 surgery MR reviewed (Pt. #12, 29, and 33) out of a total of 33 MR reviewed, P/P review, and 3 of 3 staff interviews (P, YY, T), the hospital failed to ensure that the patient/representative be informed and that the surgery consent identify the names of the First Assists and tasks to be performed.

Findings include:
Examples by surveyor #13469:

Per review, of hospital P/P Informed Consent effective date 8/05 on 1/26/12 in the AM, the policy directs the following: "Informed Consent: 5. The consent form is properly completed prior to the procedure of treatment performed, except in the case of emergencies. A properly executed informed consent form contains at least the following: Name of the practitioner(s) performing the procedure(s) or important aspects of the procedure(s) as well as the name(s) and specific significant surgical tasks that will be conducted by practitioners other than the primary surgeon/practitioner. When practitioners other than the primary surgeon/proceduralist will perform important parts of the surgical procedures, even when under the primary surgeon/proceduralist's supervision, the patient must be informed of who these other practitioners are, as well as, what important tasks each will carry out (significant/important tasks include: opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissue)."

The facility's policy titled, "Patient's Bill of Rights and Responsibilities," dated October 2009 was reviewed on 1/26/2012 at 10:05 a.m. by Surveyor #26711. On page 3, #5. Consents states in part, "a...The patient should not be subjected to any procedure without his/her voluntary, competent consent and complete understanding of the consent...," and "b. A patient as the right to know specifically who will be performing a treatment or procedure."

On page 5 of this same policy, #11. Caregiver Identity and Qualifications states in part, "a. A patient has the right to know the names, credential and roles of individuals providing service to him/her.... This includes the patient's right to know of the existence of any professional relationship among individuals who are treating him/her...."

Per interview, with OR Manager (P) on 1/25/12 at 8:45 AM, the names of surgeon first assists and the tasks to be performed by them is not currently being included in the consent for surgery per hospital P&P to ensure that the patient/representative has been informed. This is also confirmed in interview by (P) with two OR RN's (YY) and (T) on 1/25/12.


26390

Findings by Surveyor #26390:

On 1-24-2012 at 2:29 PM a review of pt. #12's MR was completed with HIM Coord. U. The record showed pt. #12 was admitted on 11-14-2011 for a Right Total Knee Replacement. The consent for surgery did not contain the name of KK, ST, 1st Assist. ST KK is listed on the Operating Room Record as the assistant for the surgery to pt. #12 on 11-14-2011.


26711

Findings by Surveyor #26711:

A MR review was completed on Pt. #29's closed surgical record on 1/26/2012 at 8:27 a.m. accompanied by HIM Coord. U. Pt. #29 had a hernia repair on 11/2/2011. 1st Assist JJ is listed on the OR record as assisting in the surgery. The surgical consent does not identify a 1st Assist or indicate what that 1st Assist will do.

A MR review was completed on Pt. #33's closed surgical record on 1/26/2012 at 9:42 a.m. accompanied by HIM Coord. U. Pt. #33 had a lymph node biopsy on 12/5/2011. 1st Assist JJ is listed on the OR record as assisting in the surgery. The surgical consent does not identify a 1st Assist or indicate what that 1st Assist will do.

These findings were confirmed at the time of the MR review and again with CNO A on 1/26/2012 at 12:15-12:30 p.m.