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29708

Based on interview and documentation in 7 of 7 inpatient medical records of Medicare beneficiaries reviewed for the "Important Message from Medicare" (Patients 5, 6, 7, 10, 11, 12, and 13), review of policies and procedures, review of patient brochures/guides and posted patient information, and review of the CMS website, it was determined the hospital failed to fully develop and implement its patient rights policies and procedures in the following areas:
* Information provided to patients did not include all of the patients rights.
* Patients rights policies and procedures lacked a process for notifying patients of their patients rights.
* The current version of the "Important Message from Medicare" (IM) form was not provided to inpatient Medicare beneficiaries as required at CFR 405.1205.

Findings include:

1. A p/p titled "General Patient Rights" dated revised "06.08" was reviewed and contained a list of patient rights. The p/p was not fully developed as it did not include all of the patient rights. For example, the p/p did not include the following patient rights:
* The patient has the right to participate in the development and implementation of his or her care plan.
* The patient has the right to have a family member or representative of his or her choice and his or her own physician notified promptly of his or her admission to the hospital.
* The patient has the right to be free from all forms of abuse or harassment.
* The patient has the right to be free from physical or mental abuse, and corporal punishment. * The patient has the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff.
The policy also contained no information reflecting provisions for how or when patients would be informed of their patients rights. It reflected only "Standard: Acute care services are provided through formal, organized Hospital service in accordance with its Mission, Vision, and Values; Hospital capacity; applicable law; and needs of patients served."

2. An undated patient brochure titled "Santiam Memorial Hospital Patient Rights" was reviewed with the QD on 01/29/2018 at 1620. He/she stated the brochure was provided to outpatients in order to inform them of their patient rights. The document included a list of patient rights that was incomplete as it lacked the same patient rights as reflected in finding 1. This was confirmed during interview with the QD at the time of the review.

3. An undated hospital "Patient Care Guide" provided to inpatients was reviewed. The guide included a list of patient rights. The list was incomplete as it lacked the same patients rights as reflected in finding 1.

4. On 01/29/2018 at 1645, the QD provided a copy of a one-page document titled "Santiam Memorial Hospital." The QD stated the document was posted in various units in the hospital. The document reflected the following: "As a patient, you are entitled to what we define as 'Patient Rights...All patient rights and patient responsibilities are defined in the Santiam Memorial Hospital Patient Rights brochure. Please ask for a copy for more information." The document included a list of patient rights that was incomplete as it lacked the same patients rights as reflected in finding 1.

5. Review of the "CMS.gov" webpage titled "Hospital Discharge Appeal Notices" stipulated that an "Updated Important Message from Medicare Form" was effective "60 days from June 29, 2017." The updated form was identified as "Form CMS-R-193 (Exp. 03/31/2020)."

Review of the copies of the IM forms provided to inpatient Medicare beneficiaries 5, 6, 7, 10, 11, 12, and 13, with admission dates ranging from 11/05/2017 through 01/29/2018, reflected the IM form used was "Form CMS-R-193 (07/10)," which was the version required prior to the updated version identified in the paragraph above.

Based on grievance report documentation reviewed for 4 of 6 patients/patient representatives that submitted a grievance to the hospital (Patients 28, 29, 31, and 32), and review of policies and procedures, it was determined that the hospital failed to implement its grievance policies and procedures to ensure it provided each patient/patient representative with a written notice of follow-up investigation and resolution that contained the required elements including: the steps taken on behalf of the patient to investigate the grievance, and the results of the grievance process.

Findings include:

1. Grievance report documentation for Patient 28 was reviewed with the CNO and IC Coordinator. The documentation reflected the "Date of Service" was 11/08/2016 and the "Date of Concern" was 03/23/2017. The "Stated Concern" reflected the patient submitted a grievance related to a "blood clot" and concerns related to tests and equipment. A written response from the hospital dated 04/05/2017, submitted to the patient in response to the grievance, was reviewed and did not contain the steps taken on behalf of the patient to investigate the grievance or the results of the grievance process.

2. Grievance report documentation for Patient 29 was reviewed with the CNO and IC Coordinator. The documentation reflected the "Date of Service" was 03/11/2017 and the "Date of Concern" was 03/20/2017. The "Stated Concern" reflected the patient submitted a grievance related to a his/her discharge. A written response from the hospital dated 03/22/2017, submitted to the patient in response to the grievance, was reviewed and did not contain the steps taken on behalf of the patient to investigate the grievance or the results of the grievance process.

3. Grievance report documentation for Patient 31 was reviewed with the CNO and IC Coordinator. The documentation reflected the "Date of Service" was 05/13/2017 and the "Date of Concern" was 05/15/2017. The "Stated Concern" reflected the patient representative submitted a grievance related to discharge instructions and provision of wound care services. A written response from the hospital dated 05/19/2017, submitted to the patient representative in response to the grievance, was reviewed and did not contain the steps taken on behalf of the patient to investigate the grievance or the results of the grievance process.

4. Similar findings were identified during review of grievance documentation for Patient 32.

5. The policy and procedure titled "Consideration of Patient and Family Concerns" dated as last revised "01/18" was reviewed. It stipulated that: "...Concerns may be addressed to staff at the time concern arises; staff will attempt issue resolution. Staff will document addressed concerns and resolutions...If a concern cannot be resolved by staff...and the concern is postponed for later resolution, referred to other staff for later resolution, requires investigation, or requires additional action, it will be categorized a grievance...In its resolution of the grievance, the hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion."

29708

Based on interview, and documentation in 2 of 14 medical records reviewed for conformance with physicians' orders (Patients 5 and 20), it was determined that the RN failed to supervise and evaluate the nursing care for each patient to ensure that physician's orders were followed:

Findings include:

1. The record of Patient 5 was reviewed and reflected the patient was admitted on 01/29/2018 at 1121 with a diagnosis of atrial fibrillation and CHF.

The record reflected a physician order for "[Oxygen] at 1-2 LPM" dated 01/30/2018 at 0826.

During a tour of the IMCU with the ICU Director on 01/30/2018 at 1540, Patient 5's room was observed. The patient was in his/her bed and no oxygen was observed being administered. This was confirmed with the ICU Director at the time of the observation. The ICU Director reviewed the patient's medical record and stated it looked like the nurse was "weaning" the patient off the oxygen. The ICU Director stated the nurse should have contacted the physician and gotten an order to change the oxygen from continuous administration to prn. He/she confirmed the patient had a physician order for continuous oxygen, and the order was not carried out at the time of the observation.

2. Review of the medical record of Patient 20 reflected a physician's order dated 11/13/2017 at 1330 that stipulated "Type & Cross match 2 units PRBC. Infuse 1 unit over 150 min. Hold 2nd unit until ordered..." The "Blood Transfusion Record" dated 11/13/2017 reflected that transfusion of one unit of PRBC was started at 1628 and was completed at 1852. The total transfusion time was 144 minutes, six minutes less than the physician's order.

An order dated 11/14/2017 at 0800 stipulated "Transfuse 2nd unit of PRBC over 150 min." The "Blood Transfusion Record" dated 11/14/2017 reflected that transfusion of the second unit of PRBC was started at 1005 and was completed at 1210. The total transfusion time was 125 minutes, 25 minutes less than the physician's order.

Based on observation, interview, and review of policies and procedures it was determined that the pharmacy policies and procedures had not been fully developed and implemented to ensure that all drugs used in the hospital were under the control of the pharmacy and were handled appropriately:
* Not all drugs available for patient use were distributed by, or under control of, the hospital pharmacy.
* Open multi-dose vials of drugs were not handled in accordance with pharmacy policies to ensure they were discarded after 28 days.
* Expired and outdated drugs were available for patient use.

Findings include:

1. Not all drugs were distributed by, and under control of, the hospital pharmacy:

* During tour of the SOC on 02/01/2018 at 0930 drugs observed on the shelves in the "nurses' station" room included but was not limited to a 5 ml. bottle of Ofloxacin Opthalmic Solution 0.3%; and a 5 ml. bottle of Dexamethasone Sodium Phosphate Ophthalmic Solution 0.1%. During interview with SOC staff at the time of the observation they stated that those drugs were not provided by the hospital's pharmacy services but were brought to the clinic by a non-hospital physician who practiced in the clinic under a contract arrangement.

2. Opened MDVs were not managed in accordance with hospital policy, and opened, expired MDVs were available for patient use:

* The policy and procedure titled "Expiration Dates or (sic) Multi-dose Vials and Suspensions" last dated "1-15" stipulated: "Multiple Dose Vials (MDV) expire 28 days after they are opened, or less if indicated by the manufacturer's label. This expiration date is written on the vial at the time of entering (sic) as well as the initials of the individual using it the first time...determine correct expiration date and label vial/bottle accordingly. Write expiration date and initial the manufacturer medication label when vial opened. Destroy any solution that has expired..."

* During interview with the DPS on 01/30/2018 at 1130 he/she stated that MDVs were good for 28 days after opening. He/she stated that the policy was that the individual who opened the MDV was to use a "Sharpie" or black marker to record on the MDV the open date, the expiration date, and their initials.

* During tour of the fluoroscopy room in the Imaging Department on 01/30/2018 at 1030 an uncapped 20 ml. MDV of Xylocaine 1% was observed on an open shelf. Two dates were handwritten on the MDV with a black marker that read: "1-8-18 2-7-18." Those dates reflected the MDV was planned to be open for 30 days. There were no initials recorded on the vial.

An uncapped 50 ml. MDV of Sensorcaine 0.25% was also observed on the open shelf. A notation hand written on the MDV with a black marker read only: "12-28 10:00." If "12-28 " was the date the MDV was opened, on the date of this observation on 01/30/2018 the MDV had been open for 33 days. There was no expiration date or initials recorded on the vial.

During interview with Imaging Department staff present at the time of the observation they stated that the policy was to "mark the date opened" on the MDV.

* During tour of the SOC on 02/01/2018 at 0930 an uncapped 50 ml. MDV of Xylocaine 2% and an uncapped 10 ml. MDV of Kenalog-40 Suspension were observed in the "nurses' station" room. Each vial had two dates, 01/29/2018 and 02/26/2018, but there were no initials of the person who opened and marked the vials.

An uncapped 50 ml. MDV of Sensorcaine 0.25% was also observed. That vial had one date recorded on it which was "1-31-18" and had no initials recorded. It was not clear if that date was the open date or the expiration date. During interview with SOC staff present during the observation they indicated that the date was the date the MDV was opened.

* During tour of the SHOTS clinic on 01/30/2018 at 1540 MDVs were observed to have stickers attached to them for recording MDV open and expiration dates.

3. Additional expired drugs available for patient use were observed during tour of the SOC on 02/01/2018 at 0930. A can of "Cold Spray Surgical Skin Refrigerant" was observed in Room 2 and was marked with an expiration date of "EXP 11/13."

Based on observation, interview, review of PM records, and review of policies and procedures it was determined that the hospital failed to ensure that all patient care equipment used, and available for use, in the hospital was tracked and included in the PM program to ensure equipment safety and reliability.

Findings include:

1. The undated policy and procedure titled "Medical Equipment Management Plan" reflected "...the Program is designed to ensure continual availability of safe, effective equipment through a program of planned maintenance, timely repair...Medical equipment may injure patients or adversely affect care decisions if not properly maintained...The hospital maintains a written inventory of all medical equipment...Equipment requiring a program of planned maintenance is listed as part of a maintenance inventory...The Biomedical Engineer will test all medical equipment on the inventory before initial usage, performs safety, operation, and functional checks...These inspection, testing and maintenance documents are maintained...for review."

The policy and procedure titled "Electrical Safety Policy" last dated 12/2017 reflected "The hospital patient must be protected from electrical hazard in relation to his susceptibility to electrical shock and his ability to protect himself..." This policy and procedure contained no direction related to inspection and maintenance of non-patient owned electrical equipment.

2. During interview with the DFP on 01/29/2018 at 1315 he/she stated that equipment throughout the hospital should have an "asset" number on a barcode, and Biomedical PM evidence should be on stickers attached to the equipment.

3. Hospital inventory and PM records for equipment observed throughout the survey were reviewed with the DFP on 02/01/2018 beginning at 1230. During interview with the DFP at the time of the review he/she confirmed the lack of inventory and PM documentation for equipment that included, but was not limited to, the following examples:

* On 01/30/2018 at 1010 an electric treadmill observed in the Imaging Department MRI Room had no visible evidence of PM. There was no PM documentation or other information about that bed.

* On 01/30/2018 at 1044 an electric exam bed observed in the Imaging Department Echo Room had no visible evidence of PM. There was no PM documentation or other information about that bed.

* On 01/30/2018 at 1046 a Welch Allyn vaginal exam light observed in L&D triage room had a blue sticker on which was recorded "Reinspect Before 10/17." There was no current PM documentation for that light and after the observation "it was pulled from the floor to PM."

* On 01/30/2018 at 1055 a Curlin Medical epidural pump observed in L&D room 235 had a white sticker on which was recorded "PM & EST Passed Date: 11/16/15 Due 11/16/16." There was no PM documentation or other information about that machine.

* On 01/30/2018 at 1125 a MAICO ERO SCAN newborn hearing test machine observed in the newborn nursery had a yellow sticker on which was recorded "MSR West Cal. Date [illegible] Cal. Due [illegible] Tech [illegible] SN [illegible]." There was no PM documentation or other information about that machine.

* On 01/30/2018 at 1200 an electric gel warmer observed in the Imaging Department Ultrasound Room had no visible evidence of PM. There was no PM documentation or other information about the warmer.

* On 01/30/2018 at 1415 a Sabina II lift observed in the PT room had a green sticker on which was recorded "Safety Checked...Date 9-13 Due 3-14." There was no current PM documentation.

* On 01/30/2018 at 1610 an MTI electric exam chair observed in SHOTS had no visible evidence of PM. There was no PM documentation or other information about the exam chair.

* On 01/31/2018 at 1102 a Crosley refrigerator observed in the M/S nutrition room had a white sticker on which was recorded "Inspected Date [blank] Initials [blank]." There was no PM documentation or other information about that machine.

* On 01/31/2018 at 1103 a Symphony Series ice machine observed in the M/S nutrition room had a SH property sticker with # 1694. There was no documentation of electrical safety inspections for that unit.

* On 01/31/2018 at 1120 a SchuKo-Vac suction machine observed in a M/S storage room had a blue sticker on which was recorded "Electrical equipment Type C Inspected 8/15 Re-inspected Before 9/16." There was no PM documentation or other information about that machine.

* On 01/31/2018 at 1121 a KCI Wound Vac observed in a M/S storage room had a white sticker on which was recorded "Battery History...Battery change due: 04/19." There was no other sticker or PM information evident. The machine was "not in hospital inventory" and there was no PM documentation.

* On 01/31/2018 at 1130 a MAC Medical warming cabinet observed in a M/S storage room had a SH property sticker with #1697. There was no documentation of PM for that unit.

* On 01/31/2018 at 1403 a jet ventilator observed on top of a code cart in the ED had no inventory or PM stickers. The device was not in hospital inventory and there was no PM documentation or other information.

* On 02/01/2018 beginning at 0930 in the SOC equipment observed without inventory or PM stickers included:
- Two multi-drawer ENT carts with built-in suction observed in exam rooms.
- A digital BP monitor observed in the "nurses' station."
- Two Welch Allyn wall-mounted exam lamps observed in exam rooms 3 and 4.

29708


Based on observation, interview, review of policies and procedures, review of manufacturer's instructions, and review of sterile processing and disinfection logs and records, it was determined the hospital failed to fully develop and implement policies and procedures for infection prevention in the following areas:
* Cleaning and disinfection supplies were expired.
* The integrity of patient care supplies was not ensured.
* Hand hygiene supplies were expired or containers were empty.
* Isolation precautions were not followed.
* Endoscope reprocessing supplies and equipment were not managed in accordance with manufacturer instructions and policies and procedures.
* Processes for disinfection and management of instruments and equipment in the SOC were not in accordance with hospital policies.
* Dirty ultrasound probe disinfection processes were conducted in the clean patient ultrasound exam room.

Findings include:

1. During tours of ICU, SPD, and SOC observations related to cleaning and disinfection supplies were made as follows:

* In SPD on 02/01/2018 at 1210 a container of Clorox bleach germicidal wipes with expiration date 07/08/2016 was observed.

* In ICU on 02/01/2018 at 1435 an open container of Clorox bleach germicidal wipes with no visible expiration date was observed in the EVS closet.

* In the SOC on 02/01/2018 at 0930 a container of "Oxivir - Virucide, Bactericide, Tuberculocide, Fungicide, Sanitizer" was observed in Room 1 and was marked with a manufacturer's expiration date of "EXP 09/11."

2. Patient care supplies were observed in packages that did not ensure the items' integrity and cleanliness, or were outdated:

* During a tour of ICU on 01/30/2018 at 1430, five oropharyngeal airway tubes were observed in the "difficult airway cart" available for patient use. The tubes were not contained in any packaging and there was no information to reflect whether or not the tubes had been used or when they had been removed from their packaging. The integrity of the oropharyngeal airway tubes could not be ensured. A hand-held suction wand was observed in a package with a hole in it. This was confirmed with the ICU Manager at the time of the observation.

* In M/S on 01/31/2018 at 1115 two vacutainers for blood specimen collection with expiration dates "01/2017" and "8/8/2017" were observed in a cabinet in room 339.

3. During tours of L&D, ED, SSU, and other areas observations related to hand hygiene supplies were made as follows:

* In L&D on 01/30/2018 at 1110 a container of hand hygiene solution with expiration date "07/2017" was observed in the EVS cart.

* In ED on 01/31/2018 at 1400 an empty wall mounted hand hygiene dispenser was observed outside a trauma treatment room.

* In SSU on 02/01/2018 at 0950 a Scrub Care surgical hand scrub dispenser with expiration "05-2017" was observed at the surgical scrub sink outside the procedure room. This was confirmed with the SSU Director at the time of the observation.

* In the conference room across the corridor from Pharmacy, a container of hand hygiene solution with expiration date "01/2016" was observed on 01/29/2018, 01/30/2018, 01/31/2018 and 02/01/2018 at the sink area. The container was nearly empty.

4. During a tour of M/S conducted on 01/30/2018 observations related to isolation precautions were made as follows:

* At 1640 a "Droplet Precautions" sign was observed hanging outside Room 337. The sign reflected the following: "STOP...Everyone Must...Clean hands when entering and leaving room...Wear mask...Family and other visitors to follow precautions..." Two non hospital individuals were observed inside the room sitting at the patient's bedside. Neither of the individuals observed had a mask on. At the time of the observation, the individuals stated they did know notice the droplet precautions sign hanging outside the room, and did not know they were supposed to wear a mask while in the room. These observations were made with the ICU Manager present.

5. During tour of the endoscope reprocessing area with the SP Supervisor on 02/01/2018 beginning at approximately 1100 the following observations were made:

* Two Medivators AERs (AER #7836 and #7837) used for reprocessing endoscopes were observed with the SP Supervisor. The AERs were observed to each have two open containers of Rapicide disinfectant solutions connected to them. The two containers of Rapicide connected to AER #7836 had no date observed or other evidence of when they were opened. The SP Supervisor stated the Rapicide should be changed within 21 days after opening and he/she confirmed there was no information reflecting how long the Rapicide had been opened.

* A manufacturer checklist for the Medivators AERs was provided and reviewed with the SP Supervisor. The checklist was titled "Daily Checklist DSD Edge" and was dated copyright "2011." The manufacturer checklist reflected the following recommended daily tasks and actions:
"Open valve on main incoming water line...Verify static water pressure is 35-40 psi (2.4-2.75 bar)";
"Check the expiration date of the Rapicide...to confirm it is within the acceptable use date...Once opened, Rapicide... can be used up to a maximum of 21 days...";
"Review 'Filter Change Log' to confirm all filters are being changed at the required pressure or time intervals...1 and .45 micron External Water Filters...Replace every 3 months or when water pressure of 40 psi cannot be maintained...0.2 micron absolute Internal Water Filter...Replace every 6 months...Air Filters...Replace every 3 months...Active Vapor Management Filters...Replace every 6 months...; and
"Confirm incoming water temperature is 35 [degrees] C +/- 2 [degrees] C..."

* The "Medivator's/Scope Buddy Daily Check Off List" for November 2017, December 2017 and January 2018 was reviewed with the SP Supervisor. The check list was designed to reflect documentation of daily monitoring of specified criteria, including water pressure and water temperature, to ensure the AERs functioned appropriately.

Documentation on the January 2018 "Medivator's/Scope Buddy Daily Check Off List" for AER #7836 reflected that for 20 out of 31 days there was no documentation reflecting the water temperature and water pressure was checked including but not limited to the following dates: 01/02/2018, 01/09/2018, 01/10/2018, 01/11/2018, 01/17/2018 and 01/29/2018. Similar findings were identified during review of the daily checklists for water temperature and pressure for AER #7836 for November 2017 and December 2017.

Documentation on the January 2018 "Medivator's/Scope Buddy Daily Check Off List" for AER #7836 reflected that the water temperature was outside the recommended range 5 out of 11 days. For example, the water temperature was recorded "40.8" on 01/03/2018; "31.5" on 01/05/2018; and "32.3" on 01/19/2018. There was no documentation reflecting actions were taken to correct the temperatures that were out of range. Similar findings were identified during review of water temperatures on the daily checklists for AER #7836 for November 2017 and December 2017.

Documentation on the January 2018 "Medivator's/Scope Buddy Daily Check Off List" for AERs #7836 reflected that the water pressure was outside the required range 11 out of 11 days. For example, the water pressure was recorded "48" and "50" on 01/03/2018; "50" and "51" on 01/04/2018; and "50" and "52" on 01/25/2018. There was no documentation reflecting actions were taken to correct the water pressure that was out of range. Similar findings related to water pressure were identified during review of the daily checklists for AER #7836 for November 2017 and December 2017. The SP Supervisor confirmed the water pressure readings were outside the required range of 35-40 psi. The SP Supervisor stated he/she had no documentation reflecting actions taken to address the water pressure.

Similar findings related to water temperature and water pressure outside required ranges were identified during review of documentation on the "Medivator's/Scope Buddy Daily Check Off List" for AER #7837 for November 2017, December 2017 and January 2018. This was confirmed with the SP Supervisor at the time of the review. The SP Supervisor stated the AERs should not have been used when the water pressure and temperature were outside required ranges until they were "cleared by maintenance." However, he/she confirmed maintenance had not been notified of the water pressure and temperature, and the AERs had been used.

Review of the "Medivator's/Scope Buddy Daily Check Off List" for #7836 and AER #7837 for November 2017, December 2017 and January 2018 reflected no information related to daily checks for Rapicide expiration and acceptable use dates, water filter changes, air filter changes and vapor management filter changes for the AERs in accordance with the manufacturer instructions. During interview at the time of the review the SP Supervisor stated he/she had no documentation reflecting that daily checks had been conducted for those items or when the various filters were changed.

Review of PM records provided for AERs #7836 and #7837 for 2016 and 2017 lacked documentation reflecting water filters, air filters and vapor management filters were changed at intervals in accordance with manufacturer instructions. During interview with hospital staff including the SSU Director and SP Supervisor on 02/01/2018 at approximately 1200, it was confirmed there was no other PM documentation for the AERs.

*The p/p titled "Endoscope Reprocessing" dated as last reviewed/revised "2/2015", was reviewed. The "High Level Disinfection" section reflected "Follow disinfectant/sterilant manufacturer's recommendations of Rapicide PA HLD solution...to achieve high-level disinfection of endoscopes...Load and connect scope or equipment per manufacture's instruction...start Medivator DSD Edge processor...The use-life of Rapicide PA high-level disinfectant/sterilant is 21 days from the open date."

* The p/p provided titled "Malfunctioning Equipment" last updated "4/2016" reflected "...Red warning tags will be supplied to all departments by Facilities Department. These tags will be used on malfunctioning equipment...Each department will be responsible for determining the immediate severity of the equipment problem and using discretion on a red flag situation...The equipment will not be used until proper service can be performed by a bio-medical technician or the Facilities Department...an email Work/Order Request Form must be completed and the...Maintenance Department...will contact the appropriate service personnel..."

6. Processes for disinfection and management of instruments and equipment in the SOC were not in accordance with hospital policies:

* During tour of the SOC on 02/01/2018 at 0930 numerous unwrapped and unprotected instruments for podiatry and ENT patient examination and treatment were observed in multi-drawer carts and cabinets in Room 1, Room 2, and the "nurses' station" room. During interview with SOC staff at the time of the observation they stated that the ENT instruments and equipment were not the hospital's property but were brought into the clinic by the ENT physician and the physician's medical assistant from another non-hospital clinic where the physician practiced and where the medical assistant was employed.

* A container of clear solution was observed in a cabinet in Room 1 and contained a mix of numerous instruments made of a variety of materials such as steel, wire, and rubber. During interview with SOC staff at the time of the observation they stated that the instruments are soaked on a daily basis in the "benz-all" solution and stay in the "benz-all" for two weeks. It was not clear how instruments placed in the solution were tracked for the period of time they were to stay in the solution. No staff present were able to clearly describe how the process worked.

* A box of 6, 40cc bottles of "benz-all" was observed. The manufacturer's directions on the box reflected that each bottle made 1-gallon of solution and required "Completely immerse thoroughly cleaned rubber or metal instruments for 15 minutes or longer." A manufacturer's insert for "benz-all" reflected "Wash instruments to remove debris and blood. Immerse instruments in BENZ-ALL for at least 15 minutes, rinse and dry." A manufacturer's "Benz-All" FAQ sheet reflected that the "diluted solution can be stored and used for up to 14 days."

* A "Benz-All Soak Log" was observed and had the following heading "(High level disinfection 15 min soak) 40cc Benz-all to 1gal distilled water." The form had three columns for "Date;" "Item;" and "Initials." In the date column the following dates were entered: 01/16/2018, 01/17/2018, 01/19/2018, 01/22/2018, 01/23/2018, 01/24/2018, 01/26/2018, 01/29/2018, 01/30/2018, and 01/31/2018. In the item column only the word "instruments" was recorded for each of the dates listed. In the initials column the same individuals initials were recorded for each of the dates listed. It was not clear what the log was intended to convey. There was no documentation to reflect that the "benz-all" solution was properly concentrated, there was no documentation to reflect what specific instruments were processed and for how long. There was no log entry for the 02/01/2018, the day of the observation, to reflect the status of the instruments observed.

* During interview with the ICC on 02/01/2018 at 1135 he/she stated that the "benz-all" was the physician's process and was not the hospital's process; that "benz-all" had not been used in the hospital since the late 1980s; that he/she was not familiar with the "benz-all" process and there was no written policy and procedure for its use in the hospital. The ICC stated that the SOC was "in transition to hospital processes."

* In a cabinet in the "nurses' station" room wrapped blue sterile packs of instruments were observed. One of which was dated "5-8-15." During interview with SOC staff at the time of the observation they stated that those packs were not processed at the hospital but were brought in to the clinic by the physician from another location. During interview with the ICC on 02/01/2018 at 1350 he/she indicated he/she didn't know anything about the instrument packs in the SOC and confirmed there was no assurance that those instruments had been processed in accordance with hospital sterile processing policies and procedures.

* Review of the hospital's policy and procedure titled "Point of Use Instrument Cleaning" dated as "Created: 1/10/2018" reflected "The Department of Surgical Services in coordination with Sterile Processing department and Hospital/Clinical Staff are responsible for proper instrument cleaning at point of use...Contaminated reusable items are...Wiped with a gauze, moistened with water (not saline) to remove gross soil from unlatched and opened instruments at point of use to prevent formation of biofilm. Unlatched and opened instruments are placed within red biohazard transport containers and covered with a gel/foam spray or enzymatic product..." The policy and procedure did not specify the product to be used as determined by the hospital's IC committee; how long those instruments were to be covered with the product and retained in the transport containers; who was responsible for transporting the containers to the Sterile Processing department; and how processed instruments would be packaged and returned to the point of use.

7. Regarding disinfection of vaginal ultrasound transducers:

*During tour of the Imaging Department on 01/30/2018 at 1200 the Cidex disinfection processing area for vaginal ultrasound transducers/probes was observed on the counter in the ultrasound exam room next to the exam room sink. During interview with ultrasound staff at that time they described the disinfection process that included steps for testing the Cidex solution, wiping the contaminated transducer after the patient's exam, soaking the transducer in Cidex, multiple rinses in water, drying, and bagging for the next patient use. That process was described to be completed entirely in the patient exam room.

* The untitled policy and procedure for disinfection of ultrasound probes with Cidex was dated as last reviewed on "11/17." It reflected that the steps described above were to be performed in the ultrasound exam room next to the "sink" but did not specify whether that was the handwashing sink or a sink for use in cleaning and disinfection processes. The policy also reflected that "Disposal of the Cidex OPA Solution: The Cidex OPA Solution is mixed with the Glute Out Neutralizer powder for 5 minutes and discarded in the hopper sink and flushed down the drain. The hopper sink is located in the ER Soiled Linen room...If the Cidex OPA Solution in secondary container does not pass Cidex OPA Test Strip test, the solution is mixed with the Glute-Out Neutralizer powder for 5 minutes and discarded in the hopper sink and flushed down the drain. The hopper sink is located in the ER Soiled Linen room." The policy and procedure reflected that the processes described in the procedure involved two separate and distinct areas, one in a patient exam room in the Imaging Department and and the other in the soiled utility room inside the ED. Further, the policy and procedure did not address how proper separation of dirty and clean would be maintained and ensured in the patient exam room, including how the handwashing sink would be dedicated for handwashing only.

* Review of the hospital's policy and procedure titled "Point of Use Instrument Cleaning" dated as "Created: 1/10/2018," and referred to in finding 6 above, reflected "The Department of Surgical Services in coordination with Sterile Processing department and Hospital/Clinical Staff are responsible for proper instrument cleaning at point of use..." That policy directed that contaminated reusable instruments were to be cleaned at point of use, soaked and transported for processing in an area or room other than the point of use exam or treatment room.

* During interview on a second tour of the Imaging Department with the ICC on 02/01/2018 at 1120 the ICC confirmed that the department lacked space outside of the Ultrasound room for disinfection of the vaginal transducers. He/she stated the closest soiled utility room was in the adjacent ED. Observation of that room inside the ED during the tour revealed the hopper sink referred to in the written policy and procedure.