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29708

Based on interview, review of policies and procedures, review of the contracted services list and review of contracts it was determined that the hospital failed to develop and implement its policies and procedures to ensure that all services furnished in the hospital under contract, were provided in a manner that permitted the hospital to comply with all applicable CoPs. All services not provided directly by the hospital were not provided under a written contract, agreement, or arrangement; written contracts for services did not contain language that ensured the contractor would comply with applicable CoPs and standards; and the hospital had not evaluated all contracted services to ensure they were provided in a manner to allow the hospital to comply with all applicable CoPs and standards. Those services were:
* Lab services;
* Pharmaceutical and sharps disposal; and
* Medical equipment maintenance and repair

Findings include:

1. The p/p titled "Clinical Contracted Services Evaluation Process," dated 08/14/2014 reflected the following: "Each calendar year, a master contract list is sent to the Administrator Manager (AM) of designee...The AM sends each responsible manager their contract list with a request for a completed contract evaluation form within a specified time frame...Site and system contracts are reviewed and the SHS Annual Contract Evaluation is completed by the appropriate individual...The AM will track all completed evaluations with noted outcomes presented to the QIC and MEC where appropriate...The Research Compliance Coordinator will send contract list updates to each AM when appropriate." The p/p included no language that required an evaluation of whether the contractor furnished services in a manner that permitted the hospital to comply with all applicable CoPs and standards for the contracted services.

2. During an interview with the VP of Patient Care Services, on 01/07/2016 at 1400, he/she indicated that some of the hospital's lab services were furnished by PeaceHealth Lab Services. However, he/she stated there was no written agreement for the services.

There was no evidence that the hospital had monitored and evaluated the PeaceHealth Lab services.

3. The contract for "Stericycle, Inc." was dated effective 04/03/2015. The document reflected an agreement for pharmaceutical and sharps disposal at the hospital. There was no language in the document that required the contractor to provide services in a manner that ensured compliance with all applicable CoPs and standards for the provision of safe and appropriate patient care. There was no evidence that the hospital had monitored and evaluated those services.

During interview with the Quality Director and VP of Patient Care Services on 01/07/2016 at 1430, they stated that the hospital had not evaluated the Stericycle services provided under contract.

4. The contract for "Valley Medical Repair, Inc." was dated effective 01/01/2012. The document reflected an agreement for medical equipment repair and maintenance at the hospital. There was no language in the document that required the contractor to provide services in a manner that ensured compliance with all applicable CoPs and standards for the provision of safe and appropriate patient care. There was no evidence that the hospital had monitored and evaluated those services.

During interview with the Quality Director and VP of Patient Care Services on 01/08/2016 at 1300, they stated that the hospital had not evaluated the Valley Medical Repair services provided under contract.

5. A list of services furnished at the hospital under contract was provided and reviewed. It did not include PeaceHealth Lab Services, Stericycle, or Valley Medical Repair.

29708

Based on interview, documentation in 7 of 7 medical records reviewed for provision of patient's rights notification (Patients 1, 2, 3, 6, 7, 8 and 10), and review of policies and procedures it was determined that the hospital failed to fully develop and implement its policies and procedures to ensure patients or patient representatives were informed of patient's rights in advance of furnishing care whenever possible as required.

Findings include:

1. The medical record of Patient 3 reflected he/she was admitted on 12/17/2015 at 1909 for a diagnosis of trauma and quadriplegia. There was no documentation in the record to reflect that the patient or the patient's representative had been informed of their rights.

2. The medical record of Patient 2 reflected he/she was admitted on 01/06/2016 at 2231 for a diagnosis of incarcerated inguinal hernia. There was no documentation in the record to reflect that the patient or the patient's representative had been informed of their rights.

3. The medical record of Patient 6 reflected he/she was admitted on 01/01/2016 at 1228 for a diagnosis of sigmoid stricture. There was no documentation in the record to reflect that the patient or the patient's representative had been informed of their rights. This was confirmed during an interview with the RN Stroke Coordinator on 01/11/2016 at 1600.

4. The medical record of Patient 7 reflected he/she was admitted on 01/07/2016 at 0029 for a diagnosis of acute DVT. There was no documentation in the record to reflect that the patient or the patient's representative had been informed of their rights. This was confirmed during an interview with the RN Stroke Coordinator on 01/07/2016 at 1400.

5. The medical record of Patient 8 reflected he/she was admitted on 01/10/2016 at 1906 and delivered a baby on 01/11/2016 at 0516. There was no documentation in the record to reflect that the patient or the patient's representative had been informed of their rights. This was confirmed during an interview with the L&D Assistant Manager on 01/11/2016 at 1700.

6. Similar findings were identified during review of the medical records for Patients 1 and 10.

7. The p/p titled "Rights and Responsibilities of Patients, Guardians, and Health Care Representatives" dated last reviewed 08/04/2015 was reviewed. The p/p included a list of hospital patient rights and reflected "SHS patients, guardians, and/or health care representatives...are expected to be aware of, understand, and comply with their rights and responsibilities as defined in this policy." However, the p/p was not fully developed to include a process for how the hospital would ensure patients were informed of their patient rights. This was confirmed during an interview with the VP of Patient Care Services on 01/11/2016 at 1440.

29708

Based on interview, review of hospital policies and procedures, and review of documentation for 2 of 2 serious adverse events, it was determined the hospital failed to ensure complete and thorough analyses of serious adverse events were conducted and corrective actions planned, implemented and tracked in accordance with hospital policies and procedures:
* The hospital failed to ensure its analysis of serious adverse events were complete;
* The hospital failed to evaluate and address all parts of the hospital that utilized similar processes and were at similar risk; and
* The hospital failed to ensure factors contributing to serious adverse events were addressed.

Findings included:

1. The hospital's p/p titled "Serious Adverse Events" dated last reviewed/revised 04/06/2015 was reviewed. It reflected "All serious adverse events that result in death or serious physical injury to the recipients of care (patients or clients) will be evaluated...to determine if the event was preventable and was within the control of the hospital to prevent...to ensure appropriate clinical and administrative responses to the patient and/or family...to determine if the incident meets the criteria of a reportable event. A root cause analysis may be conducted in order to determine the reason the event occurred and to develop processes to prevent similar events from occurring in the future...For incidents that meet the criteria of a serious adverse event, risk management and quality improvement/patient safety will...Review the preliminary information...Identify and conduct any other interviews required...Conduct a root cause analysis if indicated...Prepare and present to Administration a summary report of the incident and investigation including the proposed action(s)...Quality Improvement/Patient Safety staff will prepare a final report, including the root cause analysis, recommendations for improvement, and monitoring parameters to be submitted to the appropriate/applicable administrative committees, medical staff, and Board of Directors. Ongoing monitoring and trending information will be reported to the appropriate medical staff leadership...Final documents will be retained within the Quality Improvement Department..."

The hospital's p/p titled "Unusual Occurrence Reports" dated last reviewed/revised "5/2014" was reviewed. It reflected "The reporting of unusual occurrences is part of the hospital's risk management and quality assurance program...An unusual occurrence includes, but is not limited to, any of the following...an unintended event that causes actual or potential harm to a patient...an unanticipated adverse outcome, including unexpected complication, or harm to a patient...regardless of whether an error occurred..." The implementation section of the p/p reflected the following: "...An unusual occurrence report (UOR) shall be completed on paper or electronically by the member of the workforce or medical staff who is most directly involved in the occurrence, who first observed the occurrence, or who first became aware of the occurrence...An Unusual Occurrence Report (UOR) should be completed as soon as practical after treatment but no later than the end of the shift on which the unusual occurrence occurred...The appropriate manager(s), supervisor, or administrator will review and investigate the occurrence and provide appropriate follow-up documentation to the risk manager. This documentation may include additional information regarding the incident, further investigations required, overall outcome for persons involved in the incident, and actions taken with staff...Reports with manager/supervisor follow-up should be forwarded to Risk Management within ten (10) working days."

2. a. A UOR for an incident that occurred on 11/05/2014 at 1300 reflected that a patient sustained injury in the OR and that a RCA of the event was being conducted. There were numerous sections on the form that were not completed and were blank including, but not limited to: Referred to; Dept;
Date; Overall Effect on Individual; Details/Investigation; System/Process Problem Identified; Action Taken; Signature/Title; Additional Follow-up.

b. A RCA for the 11/05/2014 incident reflected that factors that contributed to the incident included surgical prep practices and communications.

c. A quality management worksheet provided for the 11/05/2014 incident had a reference date of 11/20/2014. There were numerous sections on the form that were not completed and were blank including, but not limited to: Procedure; Location; Surg Proc; Major Issue; Std of Care; Disposition; Referred to; Routing Date.

d. During an interview on 01/12/2016 at 1045 the Director of Quality Resources stated that the primary contributing factor for the 11/05/2014 incident was lack of communication and that staff didn't feel they could "speak up" at the time of the incident. However, he/she acknowledged that this was not reflected on the UOR or the hospital's analysis, and corrective actions to address it had not been carried out. The Director of Quality Resources stated that procedures utilizing similar surgical prep processes were performed in other parts of the hospital including ambulatory surgery and L&D. However, he/she acknowledged that although those areas were at similar risk, they had not been identified and evaluated.

3. a. A UOR for an incident that occurred on 03/03/2015 reflected that a patient sustained an injury in the OR. The report contained the incident date, the date the report was received, the location of the incident, the incident type, and a brief description of the incident. There was no other information or documentation on the report.

b. An undated case presentation report with an "Event Date" of 03/03/2015 reflected that several factors that contributed to the incident included such things as size of room, equipment, distractions, and communications. The report identified planned corrective actions but did not include how or when those were accomplished.

c. During an interview on 01/12/2016 at 1045, the Director of Quality Resources stated there was no documentation to reflect that the corrective actions planned to address the 03/03/2015 incident had been carried out. The Director of Quality Resources acknowledged that similar processes were performed in other parts of the hospital including other ORs and procedure areas that may be at similar risk. However, he/she acknowledged that those areas had not been identified and evaluated.

An interview was conducted with the Quality Director on 01/12/2016 at 1815. He/she acknowledged that the UOR for the 03/03/2015 incident was incomplete.

29708

Based on interview, review of policies and procedures, and review of contracts and other documentation it was determined that the hospital failed to develop and implement its policies and procedures to ensure that all services furnished in the hospital under contract were monitored, evaluated and tracked. All services provided under contract had not been evaluated to ensure they were provided in a manner that allowed the hospital to comply with all applicable CoPs and standards. Those services were:
* Lab services;
* Pharmaceutical and sharps disposal; and
* Medical equipment maintenance and repair.

Findings include:

Refer to the findings under Tag A083, CFR 482.12(e), Contracted Services, that reflects the hospital's failure to ensure it evaluated all patient care services furnished under contract.

29708

Based on observations, interviews, review of emergency drug monitoring records, and review of policies and procedures it was determined that the hospital failed to fully develop and implement policies and procedures to ensure that drugs and biological in emergency carts and kits throughout the hospital were managed consistently to prevent theft, misuse, and tampering. Practices related to monitoring of the contents of emergency drug carts and kits throughout the hospital were inconsistent and varied.

Findings include:

1. The undated p/p titled "Emergency Medications - System Policy" reflected the following: "All Patient Care Areas have immediate access to an emergency 'crash cart' Code cart or emergency kit. Contents of carts and kits are determined by the appropriate committee...Pharmacy is responsible for the medications stored in the carts and kits...Each cart and kit is stored and sealed to prevent unauthorized access...Each time the seal is broken, the drugs are inventoried and replenished if needed...Drugs may be removed from the cart/kit only by authorized personnel pursuant a valid physician order...A used cart is replaced with a fresh one immediately after each use...Carts and kits contain a list of medications and IV solutions on the exterior of the cart/kit. The list contains the drug name, strength, quantity, and expiration date for each drug...The cart or kit has an expiration date based upon the earliest expiration date of any drug in the cart/kit..." The p/p lacked specificity related to how often the carts were to be checked, and therefore did not provide an assurance that the integrity and contents of the cart were maintained.

An undated procedure document titled "Malignant hyperthermia patient care, OR - GSRMC" was reviewed. It stipulated the following: "Check the MH cart regularly for outdated or missing items according to the interval that has been set by your facility and after each use. Ensure that the cart is restocked as needed by an assigned licensed department or pharmacy staff member." The document included a list of IV medications, equipment and supplies that were to be stocked and maintained in the cart. The p/p lacked specificity related to how often the carts were to be checked, and therefore did not provide an assurance that the integrity and contents of the cart were maintained.

2. On 01/07/2016 at 1700 during tour of the outpatient cancer center with the pharmacist a wall mounted "anaphylaxis" emergency kit was observed. The kit contained IV medications and fluids and had a red plastic "lock" with the number 30832 on it.

An interview was conducted with the Pharmacist at the time of the observation. He/she stated that there were 3 anaphylaxis emergency kits in the cancer center. The Pharmacist provided a document titled "2015 Monthly Log" and indicated that the the only documentation he/she had for the medications in the 3 emergency kits was on the log. The log had a list of 23 items that were to be checked monthly. Only one of the items listed pertained to the emergency kits and it read "Expiration Date Anaphylaxis Kit." There were no provisions on the log for recording and tracking the "lock" number to ensure the security of the contents of the emergency kits.

3. On 01/12/2016 at 1415 during tour of the surgical services department with the Director of Surgical Services an emergency malignant hyperthermia cart was observed. The cart had a red plastic "lock" with the number 6202628 on it. A document titled "Malignant Hyperthermia Cart Contents" was located with the cart and reflected that the cart contained emergency medications and supplies. A cart checklist was also located with the cart and had columns and spaces for checks of the cart that included "Date", "Number on Lock," and "Signature." Documentation on the checklist reflected that the "lock" number and other information was recorded only 23 times between 09/14/2015 and 01/08/2016, a period of 4 months. For example, on 12/16/2015, the "lock" number was recorded 6202605. The next entry on the checklist was not until 01/08/2016, and the "lock" number at that time was recorded as 6202628. There was no documentation on the checklist to address that discrepancy.

During an interview with the Director of Surgical Services at the time of the observation, he/she stated that the cart contents and the "lock" number was only checked after the cart had been used.

4. On 01/06/2016 at 1730 in the ED the emergency code cart was observed with the VP of Patient Care Services. The cart had a red plastic "lock" with the number 6202694 on it. The cart also had a pink "Cart Restocked" sticker inside a plastic sleeve that was located with the cart. The sticker had the same "lock" number handwritten on it. An "Adult Code Cart Daily Check" form for the month of January 2016 was located with the cart. The form had columns and spaces for daily checks of the cart that included "Security Seals Intact" and "Lock # matches sticker #." There were no provisions on the log for recording and tracking the "lock" number as on the emergency cart in surgical services identified in finding 3 above.

29708

Citation Text for Tag 0749, Regulation FA22

Edwards, Wendy
Based on observation, interview, and review of policies and procedures, and other documents, it was determined the hospital failed to fully develop and/or implement policies and procedures for infection prevention in the following areas:
* Isolation precautions;
* Hand hygiene and gloving practices;
* Disinfection, cleaning and chemical monitoring processes in rehab therapy, RT department, SPD, and other areas;
* Injection and IV practices;
* Tube feeding practices;
* IC assessment in outpatient areas; and
* Hazardous waste management

Findings included:

1. a. During a tour of ICU conducted on 01/07/2016 observations were made related to isolation precautions, hand hygiene and gloving practices as follows:

* At 1040, a "Contact Precautions" sign was observed hanging outside patient room 2002. The sign reflected the following: "Stop...Perform hand hygiene on entry and exit...Put on gloves and gown before entering the patient's room. Remove PPE before exiting..." An EVS employee was observed inside the room. He/she wore gloves and a disposable gown that was not fastened and was open at the sides and back. The EVS worker touched numerous items in the room, removed the gloves and gown, exited the room, touched a supply cart that was in the hall outside the room, touched numerous containers of cleaners and supplies that were on the cart, and then touched and moved the cart down the hall to the entry of another patient room. The EVS worker did not perform any hand hygiene during this observation. This was observed with the VP of Patient Care Services present.

* At 1055, an RN was observed inside a patient room. The RN touched and disconnected the patient's epidural line with gloved hands, removed one glove and put it in his/her pocket, touched and reconnected the line using the ungloved hand, removed the other glove, touched numerous items in the room including the IV pump, a handheld scanner, and a computer mouse. No hand hygiene was observed during this observation.

* At 1105, a "Droplet Precautions" sign was observed hanging outside patient room 2103. The sign reflected the following: "Stop...Mask on entry of room. Remove before exiting." An RN was observed inside the room and had a mask on. He/she exited the room, walked across the hall, and then removed the mask. He/she did not remove the mask before exiting the room.

* At 1135, a "Contact Precautions" sign was observed outside patient room 2102, and included the same language reflected above. An RN was observed inside the room. The RN did not have gloves or a gown on. This was confirmed with the VP of Patient Care Services who was present during the observation.

2. a. During tour of the outpatient cancer center, where provider-based services were provided, with the VP of Patient Care Services on 01/07/2016 at 1600 the following observations were made:

* At 1630, in the utility room, 2 large yellow hazardous waste containers were observed and were overfilled. One of the containers had no lid. A red sharps container was also observed available for use and had no lid. This was confirmed with the VP of Patient Care Services at the time of the observation.

b. An interview was conducted with the Infection Preventionist on 01/08/2016 at 1100. He/she provided a "2015 GSRMC Infection Prevention OP Survey Tool" and stated it was a "walk through" tool that was to be used to evaluate IC needs of all outpatient buildings. It included an evaluation of numerous IC items including but not limited to the following: Infection control policies and procedures, hand hygiene, storage and use of supplies, risk analysis, medication management, safe injection practices, surface disinfection, sterilization, and isolation. However, for the outpatient cancer center identified above, the IP stated the IC tool and a "walk through" had not been completed.

3. a. On 01/11/2016 at 1540 in the ICU, the following observations were made:

* In room 2003, observation of Patient 3 reflected he/she had an indwelling urinary catheter. An RN entered the patient's room from the hallway and touched the catheter tubing that was positioned across the patient's upper thigh with ungloved hands. The RN did not perform hand hygiene during this observation.

A one liter bag of 0.9% Sodium chloride IV with tubing attached to it was observed hanging at the patient's bedside. A red sticker was attached to the tubing. The sticker had a triangle symbol and "Fri" handwritten on it, and no other information. This was confirmed with the RN at the time of the observation.

A container of Pivot 1.5 Cal tube feeding formula with tubing attached to it was observed at the patient's bedside. There was no information on the container or tubing reflecting the date or time they were initiated or last changed. This was confirmed with the RN at the time of the observation.

b. A document titled "Hand Hygiene" dated "Revised: April 03/2015" reflected the following: "Hand hygiene must occur when entering the room, before and after each patient contact..."

c. A document titled "IV tubing change" dated "Revised: April 9, 2014" reflected "Routine IV maintenance includes regular tubing changes, which help prevent such complications as thrombophlebitis and infection...Label the administration set and solution container with the date and time. Label the administration set at the proximal and distal ends to prevent dangerous misconnections if multiple lines are used."

d. A document titled "Enteral tube feeding, gastric" dated "Revised: October 02, 2015" reflected "Gastric enteral tube feeding involves delivery of a liquid feeding formula directly to the stomach...Make sure that all equipment and products are labeled with the date and time that they were first used or opened."

4. a. During a tour of the RT department with the Manager of RT on 01/12/2016 beginning at 1120, the following observations were made:

* A sink area, a pasteurizer and a dryer that were being used to clean respiratory equipment were observed. An interview was conducted with the Manager of RT at the time of the observation. He/she stated that the respiratory equipment was soaked in a "full sink of water and one cup of Endozyme," placed in the pasteurizer for further cleaning, and then dried in the dryer. The Manager of RT acknowledged there was no measuring cup or other device for measuring the amount of Endozyme used, and no fill line on the sink or other mechanism for ensuring the correct amount of water was mixed with the Endozyme.

An opened one gallon container of Endozime enzymatic detergent that was being used was observed at the sink area. The container had no information reflecting when it was opened. The container had no pump on it or other provisions for measuring it. The directions for use on the side of the container reflected information related to flexible fiberoptic instruments, surgical instruments and linens. For example it reflected: "...Surgical Instruments...Add one ounce of Endozime to one gallon of warm water...submerge instruments to be cleaned as soon as possible after use...soak for 2-3 minutes to remove organic material...rinse thoroughly in warm water, distilled water, or sterile water..."

b. The p/p provided titled "Disinfection, semicritical patient care equipment, respiratory therapy" dated "Revised: July 11, 2014" reflected the following: "This procedure covers manual cleaning and disinfection of semicritical patient care equipment used in respiratory care...Equipment cleaning...Clean the equipment meticulously with water and detergent or water and enzymatic following the manufacturer's instructions...Allow the equipment to soak for the required exposure time indicated by the device and disinfectant manufacturer's instructions for high-level disinfection."

c. Cleaning instructions for respiratory equipment were observed posted on the wall near the sink area. The instructions were titled "Cleaning Instructions for Respiratory Equipment" and had a handwritten date "Reviewed: 10/1/2013." It reflected that for sleep study equipment, "Theravest tubing," and ventilator equipment, the following instructions applied: "...Fill sink with 3 squirts of Endozime solution and fill with hot water...Soak equipment in sink for 30 minutes...Drain sink and transfer equipment to pasteurizer...Pasteurize...Place equipment in dryer on high for 4 hours or until dry...Bag equipment and tape shut...Place green 'Pasteurized on' sticker with date stamped on bags...Put away." There was no information on the instructions reflecting who reviewed them and whether or not manufacturer instructions or IC policies/procedures were considered.

5. a. During tour of the Surgical Services Department with the Surgical Services Director and VP of Patient Care Services on 01/12/2016 beginning at 1215, the following observations were made:

* At 1240, observation in OR 7 reflected the anesthesiologist reached under his/her mask, touched his/her nose and then left the OR without performing hand hygiene.

* At 1245, in OR 7, a leather briefcase was observed on a counter top area behind the anesthesia med cart.

* At 1305, in OR 7, the anesthesiologist was observed to perform a spinal injection with gloved hands. He/she removed the gloves after the injection, then touched numerous other objects and did not perform hand hygiene during the observation.

* At 1330, in OR 2, 3 syringes of injectable medications with handwritten labels were observed in the anesthesia cart available for use. One of the medication labels was torn and the name of the medication was illegible. It indicated it was prepared 01/12/2016 at 0801. The other 2 labels indicated the medications were Lidocaine and Succinylcholine and were prepared on 01/12/2016 at 0803 and 0705. At the time of the observation, the anesthesiologist stated the medications could be administered from the syringes for up to 12 hours after being prepared.

* At 1340, in OR 2, a canvas backpack was observed in the bottom drawer of the anesthesia cart.

* At 1410, in OR 2, chipped paint was observed on the entry doorframes. A wood-like shelf near the X-ray viewing box had areas of peeling laminate. The coved floor molding had numerous areas that were peeling and in disrepair. Those areas are uncleanable.

b. A document titled "Multi-dose and Single Dose Vials - System policy" with "Copyright 2016" reflected "Multi-dose and single-dose vials will be managed according to USP797 guidelines." A "797 Pharmaceutical Compounding - Sterile Preparations" document provided with "Copyright 2008" reflected the following: "Open or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products...shall be used within 1 hour if opened..." This was contradictory with the observation and interview above.

c. A document dated as "Reviewed: April 03/2015" was reviewed and reflected "...Large backpacks, bags, suitcases, or other personal items that are not wipeable (i.e. fabric bags) are not to be carried into semi-restricted or restricted areas."

6. a. During a tour of the SPD with the Director of Surgical Services and VP of Patient Care Services on 01/12/2016 the following observations were made:

* At 1445, an empty wall mounted hand hygiene dispenser was observed in the decontamination area. There were no other hand hygiene dispensers and the hand washing sink was cluttered with numerous containers of detergents and chemicals. There were no provisions for hand hygiene readily available.

* At 1500, an interview was conducted with the SPT. The SPT stated he/she used Endoyzme to clean surgical instruments prior to sterilization. He/she stated the instruments were not rinsed with water after cleaning. A one gallon container of Endozyme was observed at the time of the interview. Manufacturer instructions on the container reflected that for manual cleaning, instruments should be rinsed "thoroughly with tap, distilled or sterile water" after soaking.

* At 1515, a tray of contaminated surgical instruments was observed with the Director of Surgical Services. The instruments had visibly dried blood on them. At the time of the observation the Director of Surgical Services stated that the instruments should have been cleaned of visible matter and "soaked" as soon as possible after use prior to transport to the decontamination area in order to avoid bioburden and damage to the instruments. He/she acknowledged that the instruments had not been cleaned and soaked as they should have been.

* At approximately 1530, observations of the surgical supplies/sterile pack storage area were made with the VP of Patient Care Services. The flooring in the rolling shelving unit area was visibly dirty, peeling and in disrepair. Those areas are uncleanable. Visible dirt and dust were observed in the shelving unit floor tracks.

b. An "Instrument Cleaning" document provided with "AORN 2015 Guidelines for Perioperative Guidelines" handwritten at the top of it was reviewed. It reflected the following: "Instruments should be cleaned and decontaminated as soon as possible after use. Cleaning instruments as soon as possible after use can help prevent formulation of biofilm and dried blood. When blood or other bioburden is allowed to dry on instruments, it can become more difficult to remove. The effectiveness of disinfection or sterilization can be compromised when thorough cleaning is not accomplished...Preparation for decontamination of instruments should begin at the point of use."

c. A document titled "Decontamination of Instruments - Work Instruction, System" dated "Copyright 2016" reflected "The decontamination process for instruments and equipment will occur according to the manufacturer's guidelines and recognized standards in order to reduce bio-burden and to render the items safe to handle...All items arriving in the decontamination area of Sterile Processing are treated as potentially contaminated and are either discarded or decontaminated prior to reuse...Instrument Cleaning Procedure...Cleaning should begin as soon as possible to prevent the formation of biofilm. It is preferable to begin this process at the point of use if possible...Decontamination Process...Keep all instruments together for each type of procedure during cleaning...Use a hospital approve (sic) detergent...Rinse tray of soiled instruments thoroughly..."

7. a. During tour of the outpatient Rehab Therapy Department with the Assistant Manager and VP of Patient Care Services on 01/12/2016 at 1700, a pool used for therapy treatments was observed. The Assistant Manager stated that chemicals and water quality for the pool were checked daily by therapy assistant employees.

b. A document titled "Work Instruction - Swimex Precautions/Maintenance/Access" dated "Copyright 2016" was reviewed. It reflected the following: "Water quality standards will be in accordance with the following recommendations from Schaefer's Recreation Equipment Co...Water quality maintenance guidelines for usage of 2 - 6 hours a day..." The document reflected that the chlorine level and pH level were to be checked and adjusted 3 times a day; the acid demand and water level were to be checked daily; the total alkalinity was to be checked and adjusted weekly; and "Shock treat" was to be checked bi-weekly.

c. Another document provided titled "Swimex Work Instructions" was reviewed. The document was undated and had no information indicating who the author of the document was. It reflected "Checking chemical levels (3x Daily)...With the water testing kit check the pH, Chlorine, Water levels and Temperatures 3x during the day. Once a week check the Alkalinity level. Add chemicals as needed...Chemical levels should not be checked while patient is in the Swimex. Plan your 3 level checks around Swimex patient schedule."

d. A checklist titled "Swimex Operation Record" that was used for recording water quality and chemicals for the pool was reviewed. It had spaces for recording Total Alkalinity, Chlorine, pH, Turbidity, Temp, Quality of Chemicals Added, Remarks and Inititals. For Sunday, the checklist had one space to document chemical levels in the "AM or PM". For Monday, Tuesday, Wednesday, Thursday and Friday, the checklist had a space to document 2 times a day in the "AM" and "PM". However the documents above reflected the chemicals should be checked 3 times a day.

The records were unclear, incomplete and lacked documentation of water quality and chemical checks in accordance with the documents provided above. The following were examples:

* A "Swimex Operation Record" for the week of "12-20" was reviewed. The space following "Year" was incomplete and was blank. Results were not documented 3 times a day and there were no results documented at all for Monday, Tuesday, and Wednesday. There were no alkalinity results documented for the week. For Thursday and Friday, the turbitity was not completed and was blank.

* The "Swimex Operation Record" for the week of "1/2 - 1/9" was reviewed. The space following "Year" was incomplete and was blank. Results were not documented three times a day and there were no results documented at all for Monday, Thursday and Friday; and no results documented for Tuesday "AM" and Wednesday "PM".

* Another "Swimex Operation Record" was reviewed. The space following "Week of" and "Year" were incomplete and were blank. Results of chemical checks were recorded in the "PM" on Sunday, and 2 times a day on Monday, Tuesday, Wednesday, Thursday and Friday, and not 3 times a day.

* Similar findings were identified during review of "Swimex Operation Record" checklists provided for the weeks of "12/13 - 12/20", "12/27 - 01/01/16", and "1/10".

e. Documentation reflecting IC evaluation of the outpatient Rehab Therapy Department was requested from the Quality Director on 01/12/2016 and was not provided.