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Based on observation, interview and review of documentation it was determined that the CAH failed to ensure that all operations were approved as required by the State of Oregon hospital licensing requirements. OAR 333-515-0050, OAR 333-535-0000, and OAR 333-675-0000 require that a hospital submit building construction plans to the SA for review and approval prior to building construction/alterations for the addition of new services to the CAH's operations and for relocation of existing services. Those areas may not operate until approval to commence services is received from the SA, the Oregon hospital licensing authority:
* The CAH commenced provider-based outpatient services in two previously non-CAH provider-based clinics in 2015 without the required SA review and approval, and in one of those clinics there were construction/alterations in process at the time of the survey; and
* The CAH's Sleep Lab department was relocated to a new clinic space after construction/alterations were made to accommodate that service without the required SA review and approval.

Findings include:

1. During interview on 07/07/2015 at 1145 the CEO stated that the CAH began provider-based outpatient services in a "Phase 1" clinic in February 2015, and a "Phase 2" clinic on 07/01/2015. Both clinics were adjacent to the CAH and adjoined by a covered corridor.

The "Phase 1" clinic was observed on 07/08/2015 at 1045. The provision of services was confirmed as numerous staff and patients were observed moving throughout the clinic. Observations at that time revealed a large sheet of white Visqueen hanging in a corridor. Behind that barrier, a portion of the clinic involving multiple rooms was actively under construction as tools were evident, ceiling tiles were out of place, sections of wall in one of the rooms were unfinished and studs and pink insulation were exposed, and cabinets were uninstalled.

The "Phase 2" clinic was observed on 07/08/2015 at 1145. The provision of services was confirmed as numerous staff and patients were observed moving throughout the clinic.

The review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH had initiated the licensing plans review process prior to commencing building construction/alterations and commencing services for the addition of provider-based outpatient services.

2. During interview on 07/07/2015 at 1145 the CEO stated that the CAH moved its Sleep Lab department into a new location in the "Phase 3" clinic in 2015 and that building construction/alterations were made to accommodate the expansion of that service in the new space.

The Sleep Lab department in the "Phase 3" clinic space was observed on 07/07/2015 at 1430. Although the Sleep Lab was closed at the time of the observation, the CRM in attendance during the tour, confirmed that services were provided. During interview with the RT on 07/08/2015 at 1630, he/she further confirmed that the Sleep Lab was operational.

The review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH had initiated the licensing plans review process prior to building construction/alterations for relocation of an existing service.

Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure that the physical environment was constructed, arranged, and maintained in a safe, clean, and orderly manner for patients and staff:
* The Seclusion Room was not arranged and maintained for the safety of patients requiring seclusion;
* Oxygen tanks were not safely secured;
* Construction/alterations were in process at the time of the survey which involved the removal of a portion of exterior wall in an actively operating clinic. The resulting opening was not adequately covered to prevent the entry of rodents, pests, dust, dirt, and other debris, and to prevent break-in and entry by unauthorized persons into the clinic where drugs were stored;
* A CAH provider-based outpatient clinic was arranged and maintained for the sharing of space and operations with non-CAH providers. CAH space and operations are required to be in compliance with these Federal CoP, and State licensing, requirements. Drug and supply management and infection control precautions were not assured as those were co-mingled with unregulated non-CAH operations; and
* The CAH commenced provider-based outpatient services, and relocated its Sleep Lab department, in 2015 without the building plans review and approval required by the SA.

Findings include:

1. On 07/10/2015 at 0930 the following observations were made in the mental health Seclusion Room located on the Med/Surg Unit. That room is designed for use when ordered by a physician for patients who pose a threat to themselves or others:
* A standard hospital bed was in the room. The bed was equipped with full-length siderails on both sides. It had vertical openings along the upper portion of the headboard and openings in the footboard. The bed posed a risk to patients who were in seclusion to prevent harm to themselves or others. The siderails, the openings in the headboard and the footboard, and other features of the bed could be used to tie ligatures to.
* A standard hospital over-bed table was in the room. This mobile piece of furniture posed a risk to patients in seclusion as it could be used to harm others.
* A mobile, metal, three shelf audio-visual cart was in the room. A large TV was located on top of the cart and two electrical cords were observed to be dangling and looped around a projection from the cart. This cart, the TV, and the cords posed a risk to patients in seclusion as they could be used to harm themselves or others.
* A cage-like cover with wide gaps or openings was mounted in four places on the ceiling over a smoke alarm. The manufacturer's specifications contained the following descriptions: "...create a web of protection from vandalism and accidental damage with these UL Listed wire guards. They are constructed of 9-gauge steel wire with corrosion resistant polyester coating or 9-gauge stainless steel wire...Highly recommended for areas where abuse to smoke detectors is severe...web-like octagon shape of 9-gauge steel wire makes them extremely difficult to break...Tamper resistant hardware is available." The gaps or openings in the design allowed for a ligature to be tied to it. There were no manufacturer's specifications related to the amount of force or number of pounds that would need to be exerted on the cover to break the cover from its mounted installation on the ceiling. The specifications reflected that the cover was designed to protect the smoke alarm and to not be removable even with significant force.
* During interview with the CNO at the time of the observation he/she stated that he/she thought the "breakaway" weight was around 50 lbs. During follow-up emails with the DPO on 07/15/2015 and 07/16/2015 he/she confirmed that there was no documentation that identified a "breakaway" weight. He/she additionally indicated that the anchors used to mount the cover had a "45 lb break out strength" if a picture were to be hanging from them and "if a vertical force was applied to the wire cage the strength of the anchor is about fifteen lbs per anchor." It was not clear whether the cover would be able to withstand the weight of a small body. If the cover broke away from the ceiling it could be used for self-harm in other ways or could be used as a weapon. There was no information in the manufacturer's specifications that indicated the cover was acceptable for or endorsed for use in a Seclusion Room or psychiatric environment.
* The policy and procedure titled "Mental Health Hold Procedure", dated as last revised 08/27/2012, was reviewed. The policy and procedure contained unclear and vague directions for the management of the patient's environment and patient supervision in the Seclusion Room. Examples include but are not limited to: The only reference to furniture was: "If patient's condition is severe or patient is agitated, the bed may also be removed and mattress left on the floor without linens." "Severe" and "Agitated" were not defined in objective terms, and the language reflected the removal of the bed is optional. Another reference reflected "Mental Health Hold patients will be monitored with camera surveillance by staff at the nurses' station." However, the frequency of observation was not specified. Additionally, "All hold patients with a locked door will be physically visualized and documented by a staff member or Mental Health attendant (sitter) every 15 minutes." Fifteen minutes would be adequate time for a person to attempt self-harm with the furniture and ceiling ligature possibilities present in the room.

2. On 07/07/2015 at 1430 in the Sleep Lab utility room, four Oxygen "E" tanks were observed standing upright and were not secured to a wall or any stabilizing cart or fixture. Those tanks have the potential to explode or to ignite a fire if not properly positioned and secured.

3. The "Phase 1" clinic was observed on 07/08/2015 at 1045. The provision of services was confirmed as numerous staff and patients were observed moving throughout the clinic. Observations at that time revealed a large sheet of white Visqueen hanging in a corridor. Behind that barrier, a portion of the clinic involving multiple rooms was actively under construction as tools were evident, ceiling tiles were out of place, sections of wall in one of the rooms were unfinished and studs and pink insulation were exposed, and cabinets were uninstalled. From within one of the rooms a large cutout, approximately six feet high and four feet wide, in an exterior wall was also observed. It had been covered with a large piece of plywood which did not completely cover the cutout. There were gaps on both sides and at the bottom that allowed the outside air into the clinic and provided for the entry of pests and rodents. In addition, the ill-fitting plywood allowed a security risk and left the clinic, in which drugs were stored, vulnerable to break-in and access by unauthorized persons.

4. During interview on 07/07/2015 at 1145 the CEO described the operations within the "Phase 1" clinic. The CEO stated that the clinic housed the operations of CAH provider-based outpatient services, and the operations of non-CAH outpatient services. The CEO stated the non-CAH outpatient services were not consistently provided in non-CAH dedicated space, and that there were times when those services were provided in the CAH provider-based spaces.

The "Phase 1" clinic was observed on 07/08/2015 at 1045. "Phase 1" clinic staff was interviewed at that time and confirmed that the CAH provider-based outpatient services and the non-CAH outpatient services were not conducted in distinctly and clearly separate spaces. The lack of separate CAH operations was further demonstrated as clinic staff stated that CAH staff perform medical assistant duties for all but two of the non-CAH providers. It was not clear whether those staff were performing as CAH employees on those occasions.

Refer to the findings related to observations in the "Phase 1" provider-based clinic, at Tag C276, CFR 485.635(a)(3)(iv), regarding drug management, and Tag C278, CFR 485.635(a)(3)(vi) regarding infection control precautions.

5. Refer to Tag C153, CFR 485.608(c), Licensure of CAH, which reflects that building construction/alterations had been completed for the relocation of Sleep Lab services; that building construction/alterations were in process in the "Phase 1" provider-based clinic; and that "Phase 2" provider-based clinic operations had commenced in a previously non-provider based clinic, without the required building plans review and approval of the SA.

Based on observation, interview, and review of equipment logs, it was determined that the CAH failed to fully develop and implement systems and policies and procedures to ensure that all electrical and bio-medical patient care equipment had been maintained to ensure an acceptable level of safety and quality:
* All patient care equipment throughout the CAH had not been incorporated into a clear and complete inventory;
* Documentation did not reflect initial PM inspections on all equipment prior to being put into service for patient use;
* Documentation did not reflect timely PM inspections had been conducted for all patient care equipment that was in use or was available for use; and
* Used patient care equipment was available for patient use without evidence that the equipment had been processed, inspected and evaluated for safety, accuracy, and efficacy.

Findings include:

1. No written policies and procedures for equipment PM were provided as requested on 07/07/2015 and 07/10/2015. The CRM confirmed in an email received on 07/13/2015 at 1534 that there were no policies and procedures for equipment PM.

2. During interview with the CEO and the DPO on 07/07/2015 at 1420 it was verified that equipment should be identified with inventory numbers and PM inspection labels. However, the CEO stated that items that cost more that $5,000 should have those and items that cost less than $5,000 were less likely to have those.

3. The DPO was interviewed on 07/09/2015 at 1230. He/she stated that all new equipment into the CAH is to be received by the purchasing department. From purchasing the equipment is sent to plant operations for assembly, if indicated, and electrical testing. The equipment is returned to purchasing where it is "tagged and logged" for inventory purposes. From there it goes to the unit or department it is assigned to.

The DPO stated that the assembly and electrical testing activities done by plant operations staff are not documented or recorded.

The DPO stated that each department Director is responsible for the Biomedical inspections for all equipment in their departments. He/she indicated that Biomedical contractor last visited in March of 2015, and confirmed that plant operations staff do not formally communicate with the Biomedical personnel.

4. Two lists of patient care equipment were reviewed. One list was provided by the CAH's purchasing department and was identified as "Equipment Inventory Lake District Hospital." The equipment on that list was identified with a four digit number. The second list was provided by the CAH's Biomedical Services contractor and was identified as "Active Equipment List for LDH 07/09/2015." The equipment on that list was identified with a four digit number different than the number on the "Equipment Inventory" list and was preceded by "LDH." For example: "LDH0010." While some equipment was identified on both lists, some was not.

5. During tours conducted throughout the CAH during the survey, observations of patient care equipment revealed that some equipment was identified with no inventory number, some with one inventory number, and some with two different inventory numbers. In addition, some equipment had PM inspection labels evident, while some did not. Some PM inspection labels reflected that equipment was past its "Inspection Due" date. Review of equipment against the lists identified in finding 3 above also reflected some equipment was not located in the department specified on the lists. Discrepancies identified include:

On 07/07/2015 at 1300 in the Radiology Department equipment observed included:
* A Biodex SoundPro Ultrasound table had no visible inventory number and PM label, and was not found on the equipment lists.
* A GE Ultrasound Logiq E9 had no visible inventory number and PM label, and was not found on the equipment lists.
* An electric "Warmer" was identified with property/inventory number 3774 and had no visible PM label.

On 07/07/2015 at 1430 in the "Phase 3" clinic space and Sleep Lab equipment observed included:
* A hydraulic Hoyer lift was identified with property/inventory number 3391 and had no visible PM label.
* Two Phillips Respironics System One Sleep Apnea Therapy Platforms had no visible inventory numbers and PM labels, and were not found on the equipment lists.
* Three Nihon Kohden Neurofax Sleep Study machines had no visible inventory numbers and PM labels, and were not found on the equipment lists.

On 07/07/2015 at 1635 in the Laboratory equipment observed included:
* A Thelco Dryer was identified with property/inventory number 1985 and no PM label.
* A CT-1 Blood Bank refrigerator was identified with property/inventory number 1777 and no visible PM label.
* A centrifuge was identified with two property/inventory numbers LDH0155 and 2583 and no visible PM labels.
* A Micro Typing MTS Centrifuge was identified with property/inventory number LDH0321 and no visible PM label.

On 07/08/2015 at 1045 in the "Phase 1" provider-based clinic equipment observed included:
* An Elite Natus Model 100 Doppler was identified with property/inventory number 6122 and no visible PM label.
* A Welch-Allyn SureTemp Plus had no visible inventory number and PM label.
* A Welch-Allyn EKG machine was identified with property/inventory number 6195 and no visible PM label.
* A Hyfrecator 2000 Electrosurgical Unit was identified with property/inventory number 6166 and no visible PM label.
* A Ritter M11 Ultraclave Autoclave had no visible inventory number or PM label.
* An Attest Steam Incubator had no visible inventory number or PM label.
* An exam lamp was identified with property/inventory number 1747 and no visible PM label.

On 07/08/2015 at 1145 and 1700 in the "Phase 2" clinic, where the CAH commenced provider-based outpatient services on 07/01/2015, equipment observed included:
* Two Welch-Allyn SureTemp Plus had no visible inventory numbers or PM labels
* A Pelton & Crane Sterilizer had no visible inventory number or PM label.

On 07/09/2015 at 1020 in the decontamination room in the ED entry equipment observed included:
* A Gomco Pump Model 6037 was identified with property/inventory numbers LDH0059 and 3699, and a PM label that indicated "Inspection Due 03/2015." The pump was not identified on a list attached to the Biomedical Services list that was titled "Equipment not located at LDH the month of 03/01/2015."

On 07/09/2015 at 1315 in the SPD equipment observed included:
* A Steris Harmony LED585 Surgical Lighting and Visualization System had not visible inventory number or PM label, and was not found on the equipment lists.

On 07/08/2015 at 1510 in the Cardiopulmonary Rehab Department and adjacent storage equipment observed included:
* An EKG Treadmill was identified with property/inventory numbers LDH0236, LDH0237, and 3957 and no visible PM label.
* A Viasys LTV1200 Ventilator was identified with property/inventory numbers LDH0064 and 3763 and no visible PM label.
* A Fisher & Paykel HC201 Humidifier had no visible inventory number or PM label.

On 07/08/2015 at 1620 in the Pulmonary Rehabilitation Department equipment observed included:
* A Horizon Fitness RC-30 Exercise Bicycle had no visible inventory number or PM label.
* A Quinton Hyperdrive Treadmill was identified with property/inventory number 1539 and no visible PM label.
* An Invivo MDE Escort Prism Vital Signs Monitor was identified with property/inventory number LDH0244 and no visible PM label. The monitor was identified on the Biomedical Services list as located in the Critical Care Unit.
* A Medtronic Lifepak Defibrillator was identified with property/inventory number LDH0024 and no visible PM label. The defibrillator was identified on the Biomedical Services list as located in the Outpatient Surgery Department. That machine had a piece of tape over some of the control with the writing "Do Not Use AED." No explanation for that was evident.
* A Respironics REMstar Pro M Series CPAP machine was identified with property/inventory number 5677 and no visible PM label. That machine had a patient wrist band, with a patient's name, attached to it. In addition, a second machine, a Respironics BIPAP Plus M Series was identified with property/inventory number 5676 and no visible PM label. During interview with the RT at that time, he/she stated that the two machines were "used" and had been "donated" by the owners for use by other patients. He/she confirmed that the machines had not been inspected by Biomedical personnel.

6. No written policies and procedures for management of used/donated equipment were provided. The CRM confirmed in an email received on 07/13/2015 at 1534 that there were no policies and procedures for used/donated equipment.

Based on observations, interviews, and review of documents and records it was determined that the CAH failed to fully develop and implement policies and procedures to ensure that drugs and biological were stored, handled, and managed in accordance with accepted professional principles:
* Drugs and biologicals, including narcotics, were not controlled and secured to prevent theft, misuse, and tampering; and
* Outdated and otherwise unusable drugs were available for patient use, including expired drugs, drug manufacturer's samples, filled patient prescriptions, opened and used MDVs of injectable drugs; and opened and used topical and liquid drugs.

Findings include:

1. The policy titled "Outdated Departmental Pharmaceuticals" dated last reviewed "5/14/14" reflected "Pharmacy will check for outdated medications in all departments once a month...Pharmacy will have a list of all medications available in each area of each department with a space provided for each medication's expiration date...Upon replacement of each outdated or restocked medication the new expiration date shall be reposted on the area list."

2. A policy and procedure titled "Storage of Multi-dose Vials After Opening", with a review date of 05/14/2014, was reviewed. It stipulated that "The individual opening any multi-dose vial shall initial and date the vial at the time of opening...The following medications shall be discarded after 24 hours...Other medications, if stored appropriately, may be kept for 28 days after opening or until the date determined by the pharmacist...All vials must be stored according to manufacturer's recommendations."

3. A policy and procedure titled "Emergency Crash Carts Procedure", dated as revised 08/2009, stipulated that "All crash carts will be checked every shift by nursing personnel and the check list will be initialed and signed as indicated...Intubation trays are to be maintained and checked monthly by Cardiopulmonary staff..."

4. A policy and procedure titled "Sales Representatives: Visitation Guideline", with a review date of 05/14/2014, was reviewed. It stipulated: "Medical Sales Representatives shall...sign in with the hospital's Material Management Department and pharmaceutical representatives shall sign the log in the pharmacy...must be accompanied at all times by a hospital employee...Representatives are not allowed in any patient care areas...Contact is not permitted with physicians on hospital property without prior arrangement...Medications not on the formulary shall not be detailed. Pharmaceutical sales representatives shall detail products only according to approved FDA-guidelines and facility-approved guidelines...Distribution of pharmaceutical samples and acceptance by hospital staff is strictly prohibited..."

5. On 07/07/2015 at 1430 in "Phase 3" clinic space drugs and biologicals observed included:
* One-gallon container of Biofreeze Pain Relieving Gel had an expiration date of 06/2005

6. On 07/07/2015 at 1500 in the surgical services department drugs and biologicals observed included:
* The Anesthesia Office door was unlocked and open. Two anesthesia carts were observed inside the office. One of the carts, referred to by staff as Anesthesia Cart 2 was unlocked and contained multiple medications that were accessible and unsecured. Nobody was observed monitoring the cart at the time of the observation.
* The bottom drawer of Anesthesia Cart 2, observed with the CRNA present, contained an unlocked tackle box with multiple emergency and narcotic medications inside including but not limited to the following: Alfentanil 1000 mcg/2 ml; Ephedrine 50 mg/1 ml; Fentanyl 100 mcg/2 ml; Fentanyl 250 mcg/5 ml; and Hydromorphone 2 mg/1 ml.
*An undated document titled "Anesthesia Box #2" that was with the tackle box was reviewed. It had a list of 11 medications including those listed above. The bottom portion of the document had a section for recording medications that had been wasted. That section had columns for the Date, Pt. Name, Pt. Number, Waste Cosign and Medications. Many of the entries were illegible, written over and obliterated. The following were examples:
* The first entry dated "6/25/15" was for Fentanyl 100 mcg/2ml and had an illegible Pt. Name. The Pt. Number and the "Waste Cosign" section was not completed and was blank. It was unclear whether the medication was administered or wasted.
* The second entry was for Ketamine 500 mg/10 ml and had an illegible Date, Pt. Name and Pt. Number. The "Medications" section for the Ketamine 500 mg/10 ml had an entry that was obliterated and illegible. There was no documentation to reflect the author, date, or the reason for the obliterated entry.
* The third entry dated "6/29/15" was for Fentanyl 100 mcg/2ml and had an illegible Pt. Name.
* Another entry for Fentanyl 100 mcg/2ml had an illegible Date and Pt. Name, and the "Waste Cosign" section was not completed and was blank. It was unclear whether the medication was administered or wasted.
* During an interview with the CRNA at the time of the observation, he/she stated that the only tracking of the medications in the cart was when the tackle box in the bottom drawer was brought to the pharmacy to be replaced every two weeks and "as needed" for restocking. He/she also stated that CRNAs were responsible for checking the cart monthly for expired medications.
* During observation of "Anesthesia Cart 1" with the CRNA, the following expired medications were observed: Atropine Sulfate injectable with expiration date 06/2015; Naropin 0.2 percent injectable with expiration date 06/2015; and 3 vials Cefaxitin 1 gram injectable with expiration dates 06/2015.

7. On 07/08/2015 at 1045 observations in the "Phase 1" provider-based clinic drugs and biologicals observed included:
* 12 bottles of Pedialyte electrolyte solution were stored in a refrigerator. Manufacturer's instructions for storage on the labels specified "Store at room temperature; Avoid extreme temperatures."
* Multiple MDV of injectable medications were uncapped and used and there was no indication as to when the MDVs had been opened. Those MDVs included Kenalog-40, Lidocaine & Epinephrine, Sotradecol, Marcaine, 8.4% Sodium Bicarbonate.
* A 15 ml "Sterile" bottle of Proparacaine Hydrochloride Opthalmic drops was open and used and the outside of the bottle was covered with residue and grime
* Numerous boxes of drug manufacturer's samples were available for use. Those included Eliquis, Chantix, Jardiance, Tradjenta.

8. On 07/08/2015 at 1145 observations in the "Phase 2" clinic, where the CAH commenced provider-based outpatient services on 07/01/2015, drugs and biologicals observed included:
* The "injection room" and the autoclave room, in which hundreds of drugs were stored, were unlocked or open
* The "injection room" and the autoclave room were cluttered and disorganized. Old, outdated, and new drugs, supplies and miscellaneous items were co-mingled and packed every shelf, counter, and cabinet. The surfaces were covered with dirt, debris, and dried spills
* Two 30 ml Lidocaine Hydrochloride Jelly tubes had expiration dates of 01/2011
* Lidocaine Ointment had an expiration date of 05/2004
* Two bottles of Lidocaine Hydrochloride had expiration dates of 04/2010
* Three ampules of injectable Narcan had expiration dates of 05/01/2004
* A SDV of Narcan had an expiration date of 04/01/2006
* A MDV of Bacteriostatic Water for injection had an expiration date of 02/2006, and documentation on the label reflected the vial had been uncapped and used in 07/2011, five years after the expiration date.
* A MDV of Cyanocobalamin with a prescription label for a specific patient had an expiration date of 08/2013. The MDV had been uncapped and used and there was no indication as to when that had occurred.
* 21 SDVs of Hydroxyzine (Vistaril) had an expiration date of 07/2013. A yellow "sticky-note" attached to the box of expired vials read "Don't throw away give to [physician's name]"
* Two urine specimen containers were observed with a multicolored thick to hardened substance inside of them. The only identifying information on them was written by hand as "7/17/14 Monsel's Solution"
* A large spray bottle of dark solution was identified only as "Matar", there was no other information or wording on the bottle.
* A large brown bottle of solution was identified only as "Bunnells Solution", there was no other information or wording on the bottle.
* A box of 250 ml bags of Lactated Ringers IV solution was observed and all of the bags had an expiration date of 02/2015
* Five 30 ml bottles of liquid Morphine had expiration dates of 08/2013, 03/2014, 07/2014, and 02/2015. There was no corresponding narcotic count sheet for any of the five bottles and four of those bottles had been opened. Two bottles each had approximately 18 mls of solution visible, one bottle had approximately 24 mls of solution visible, one bottle had approximately 30 mls of solution visible. There was no record to reflect the disposition of the missing mls and no assurance that the solution in the bottle was morphine.
* A bottle of liquid Morphine with a patient-specific prescription label reflected it was to be discarded 01/21/2014. The expiration date of the Morphine had been covered by the label.
* 38 prefilled syringes of Morphine Sulfate had expiration dates of 05/01/2015
* Five ampules of Dilaudid for injection had an expiration date of 07/2014
* A bottle of 75 tabs of Endocet (Oxycodone and Acetominophen) had an expiration date of 12/2013
* Two bottles of a solution were labeled with a patient name and identified only as "Dilution 1:100 Extract 5A"
* An "Anaphylaxis Kit" contained three SDVs of Hydroxyzine with expiration dates of 09/2010 and 07/2013; three doses of Claritin with expiration dates of 07/2008; and a dose of Doxepin Hydrochloride with an expiration date of 02/2009
* MDVs of Novolog and Humalog insulin had expiration dates of 02/2012, 05/2012, and 12/2014
* A box of Acetaminophen suppositories had an expiration date of 08/2003
* In excess of four hundred containers of drug manufacturer's samples were available for patient use and many were outdated, including, but not limited to: Caduet had an expiration date of 06/2009; 16 Boxes of Altace had expiration dates ranging from 03/2008 to 08/2009; 30 bottles of Enjuvia had expiration dates ranging from 12/2008 to 02/2010; Multiple containers of Asmanex TwistHaler had expiration dates ranging from 12/2009 to 06/2011; Four boxes of Strattera had expiration dates ranging from 04/2011 to 05/2012.

9. On 07/08/2015 at 1510 in the Cardiopulmonary Rehab Department and adjacent storage drugs and biologicals observed included:
* The five drawers of a red emergency code cart were secured with a numbered, red breakaway "lock", #2920347. Five other numbered, red breakaway locks were observed on top of the cart. There was no code cart checklist or other document visible to reflect when the "lock" #2920347 had been placed and by whom. There was no document or system visible to reflect, that since the time "lock" #2920347 had been placed, the "lock" had remained intact and the "lock" # verified to ensure the security and integrity of the emergency drugs contained within.
* During interview with the RT at the time of the observation, he/she confirmed that there was no system for checking and documenting the integrity of the "lock" or the medications within and that he/she wouldn't have any way of knowing if the cart had been opened and a new "lock" with a different number placed.
* During the observation the "lock" was broken and the contents inside observed. A tray of drugs was observed in the first drawer. There were no other drugs or supplies of any kind in the remaining four drawers. The RT stated at that time he/she did not know that there were no emergency supplies in the four drawers of the code cart.
* A "Code Tray Medications" list attached to the cart contained a list of medications with a quantity next to each. However, a policy and procedure provided, titled "Cardiac Stress Test" and dated as revised "09/27/2002, contained a list of "Equipment, Crash Cart and Drugs" that did not match the "Code Tray Medications" list. The policy and procedure drug list included Lidocaine, Nitroglycerin, Isuprel, Heparin and D5W 500cc IV solution. Those drugs were not on the "Code Tray Medications" list attached to the cart, and drugs on that list were not in the policy and procedure.

10. Review of 2015 pharmacy records reflected "Outdating Logs" for surgery and anesthesia departments. Those logs reflected that surgery and anesthesia staff persons recorded their initials monthly to indicate that they had checked all medications in those departments, including in anesthesia carts, for expired drugs. The instructions at the bottom of the log was "Turn in a copy of this page to pharmacy each month after outdating."

11. The Pharmacy Director was interviewed during tour of the pharmacy on 07/09/2015 at 1015.
* In regards to hospital-wide pharmacy systems the Director stated that the pharmacy staff is responsible for checking inventory and outdates in all departments except for surgery, anesthesia, and the provider-based clinics. The Director stated those departments manage their own drugs and outdates. The Director provided 2015 pharmacy records that reflected "Outdating Logs" for surgery and anesthesia departments. Those logs reflected that surgery and anesthesia staff persons recorded their initials monthly to indicate that they had checked all medications in those departments, including in anesthesia carts, for expired drugs. The instructions at the bottom of the log was "Turn in a copy of this page to pharmacy each month after outdating."
* In regards to the use of drug manufacturer's samples for CAH patients the Director stated that "We don't use them in the hospital...We don't use samples."
* In regards to the use of MDVs the Director stated that the policy was that MDVs are to be discarded 28 days after opening. He/she stated that "staff is supposed to use" a yellow sticker that is to be placed on the MDV. The yellow sticker was observed. It had a place for "Date Vial Opened:", "Date Vial Expires, and it directed "Discard after 28 days."
* In regards to emergency code cart numbered "locks", the Director stated that there was a supply of red, numbered "locks" distributed for each cart because the "pharmacy doesn't have responsibility for all of the carts."
* In regards to the lack of a system for ensuring drug security and integrity in the Cardiopulmonary emergency code cart the Director stated that staff "should be tracking the lock #s."

12. During further interview with the pharmacist on 07/09/2015 at 1700 he/she stated that the pharmacy tech who had been checking for outdates in the Cardiopulmonary emergency code cart had not been documenting the occasions he/she had broken the numbered "locks", accessed the drugs, and placed a new numbered "lock". In that case, the lack of a tracking system used by pharmacy staff and Cardiopulmonary department staff, in conjunction with the presence of a stock of numbered "locks" on the cart, allowed opportunities for individuals to access the drugs for purposes of theft or tampering without being detected.




29708

29708

Based on observation, interview, and review of policies and procedures, and other documents it was determined the CAH failed to fully develop and implement policies and procedures for infection prevention in the following areas:
* Hand hygiene practices were not in accordance with written polices and procedures.
* Isolation Precautions were not in accordance with written policies and procedures.
* MDVs were not managed in accordance with written policies and procedures.
* Humidity and temperature levels in the ORs and other areas were not clearly and consistently monitored.
* Cleaning, disinfection, and sterile processing supplies and processes in surgical services, respiratory therapy services, and other areas were not in accordance with manufacturer's instructions and current, written CAH policies and procedures.
* Outdated patient care, laboratory testing, disinfectant, and hand hygiene supplies were available for use. The adequacy, efficacy, and reliability of the supplies for their intended purpose is not ensured when used beyond the expiration date.
* Patient care and housekeeping supplies were not stored in original containers or were unclearly labeled, and manufacturer's instructions including, but not limited to, indications for and proper use, were not evident on those secondary containers.

Findings included:

1. On 07/07/2015 at 1510 the outside of patient room 113 was observed with the RN Case Manager. The door to the room was open and a "Contact Precautions" sign was posted on the doorframe. The sign reflected the following instructions: "...Wear gown to enter the room. Discard gowns in the room...Wear gloves when entering room. Change...After Care...Perform hand hygiene." A CAH individual was observed inside the room. The individual was wearing a gown and gloves. The individual handled/touched the patient's privacy curtain and then stepped outside the room to the hallway and removed the gown and gloves. He/she then walked across the hallway, entered a utility room and performed hand hygiene in the utility room. The individual did not remove the gown and gloves or perform hand hygiene before leaving the patient's room. These observations were confirmed with the RN case manager at the time of the observation.

The policy and procedure titled "Guidelines for Isolation Precautions (Transmission Based)" dated as "Date revised: 11/15/2011" reflected "Transmission Based Isolation Precautions following CDC recommendations are followed to protect against the spread of pathogens within the hospital facility...Once initiated a sign naming specific type of precautions to be used and guidelines for this is placed on the door outside the patient's room...Staff, patients, and visitors are to comply with isolation precautions as indicated...Gloves (clean, non-sterile) are to be worn when entering room...Remove gloves before leaving patient's environment and wash hands immediately with antimicrobial soap and warm water...Wear gown if patient is incontinent, has diarrhea...Remove gown and discard before leaving room."

The policy titled "Infection Prevention Procedures" dated as "Date revised: 5/29/2013" reflected: "...Wash hands or use hand sanitizer gel before and after contact with patient, glove use..."

2. On 07/09/2015 at 1100 the ED soiled utility room used for cleaning instruments was observed with a CNA and the CNO. The CNA stated that instruments brought to the room were not wiped down prior to being cleaned and he/she did not know how long the instruments may remain in the room before they would be cleaned. He/she stated "We don't have a time frame for that." The CNA stated that for cleaning the instruments he/she used "2 squirts" of Enzol and "enough water to cover the instruments." He/she acknowledged the water was not measured in order to ensure appropriate dilution of the Enzol. A brush with wire and nylon bristles was also observed in the soiled utility room. The CNA stated the brush was used during the cleaning process to scrub debris from the instruments. The CNA stated he/she did not know how often the brush was cleaned or when it should be replaced.

During an interview with the OR manager/IC RN on 07/09/2015 at 1815, he/she confirmed that the CAH had no policies and procedures for cleaning instruments in the ED.

3. On 07/09/2015 at 1320 during tour of the SP decontamination area with the ST and CST, a graduated cylinder containing various wire and plastic brushes and a 60 ml syringe used for cleaning surgical instruments was observed at the sink area. During an interview at the time of the observation the CST and ST indicated that the brushes were used until they "showed wear and tear" and were then cleaned with water and "Enzol." The CST stated he/she did not have any manufacturer recommendations or other instructions related to how the brushes should be cleaned or how long the brushes should be used before they were discarded. The ST stated that when cleaning surgical instruments prior to sterilization he/she dispensed "4-5 squirts of Enzol" in the sink and then "ran water over the instruments." The ST stated he/she did not measure the amount of water used and did not soak the instruments prior to removing them from the solution.

An open bottle of Enzol that was being used was observed at the time of the interview. The label on the bottle reflected the following manufacturer instructions: "Directions For Use...Add 1 ounce (1 pump) of Enzol Enzymatic Detergent liquid concentrate per gallon of water. For equipment with dried-on organic matter, use 2 ounces per gallon of water and/or use warm water. ..Soak equipment, immediately after use, until all organic matter is dissolved and removed. A minimum soak of 1 minute is recommended. Extended soak time for equipment with dried-on organic matter..."

4. On 07/09/2015 at 1340 during tour of the SP with the ST and CST an open box of BIs that was being used was observed. Information on the side of the box reflected that the BIs should be stored in an environment that was between 59 and 86 degrees Fahrenheit; and 35-60 percent humidity. During an interview with the CST at the time of the observation, he/she stated that surgical services staff did not monitor the temperature and humidity, and he/she had no documentation of temperature and humidity monitoring in the area where the BIs were stored.

During an interview with the OR manager/IC RN on 07/09/2015 at 1815 he/she confirmed that the CAH had no policies and procedures for BIs, including how the BIs should be stored.

5. On 07/09/2015 at 1430, in the procedure room an endoscope was observed with the OR manager/IC RN and the ST. The ST stated that when pre-cleaning the scope prior to placing it into the scope processor, he/she dispensed "10 pumps Enzol" into the sink and then "ran just enough water to cover the scope." The ST stated he/she did not measure the amount of water used to dilute the Enzol solution. Also during the observation, a port was observed on the scope. The port was referred to by the OR manager/IC RN as a "biopsy port." The ST stated that he/she did not flush or clean the port at any time during the cleaning process.

6. On 07/09/2015 at 1445, a Steris System IE processor was observed with the OR manager/IC RN and the CST. During an interview with the OR manager/IC RN at the time of the observation, he/she stated that the processor was used for sterilizing endoscopes. An opened container of chemical indicator strips that was being used to test the sterilant in the processor was also also observed. The manufacturer instructions on the container label reflected "For routine monitoring of the System IE Liquid Chemical Sterilant Processing System..." The label also reflected "Date Opened" with a line after it that was not completed and was blank; and "New Expire" with a line after it that was not completed and was blank, followed by "6 months, not greater than expiration date." There was no evidence reflecting when the container was opened in order to determine when the strips expired. This was confirmed with the CST at the time of the observation.

A scope storage closet was observed at 1450 with the OR manager/IC RN and the ST. Several scopes were observed hanging vertically in the closet. A towel was observed on the floor of the closet underneath the scopes. During an interview conducted with the ST at the time of the observation, he/she stated the towels were placed in the closet because the scopes were "still dripping" when he/she hung the scopes in the closet to be stored.

A policy titled "Endoscope Cleaning Procedure" dated "Date Issued: 8/2008" reflected "...Manual Cleaning Procedure....Immerse scope in freshly prepared detergent solution. Clean all external surfaces. Brush endoscope distal tip and biopsy channel...Soak endoscope in detergent for a minimum of one minute or as recommended by detergent manufacturer..." The policy further reflected "Drying...Ensure that endoscope is completely dry before storing." During an interview conducted with the OR manager/IC RN on 07/09/2015 at 1815, he/she stated that the policy and procedure was not fully developed to include the "Steris System IE" processor the CAH was currently using to reprocess scopes.

A policy titled "Terminal Disinfection/Sterilization Procedure" dated as "Date revised: 8/21/2012" reflected "The following guidelines are to be followed for disinfection/sterilization of reusable items through the use of a chemical germicidal approved by the Infection Control Committee...Semi-critical - Items that come in contact with mucous membranes or non-intact skin including, but not limited to, respiratory therapy equipment, anesthesia equipment, bronchoscopes, gastrointestinal endoscopes...The chemical germicidal solution will be mixed and used according to the manufacturers written instructions. Factors that influence germicide efficacy...Prior cleaning and rinsing of the item; Type of bioburden on the item; Concentration of the chemical germicide; Exposure time to the chemical; Physical configuration of the item...crevices, hinges, lumens, etc...After activation of the chemical germicide, an expiration date that is in accordance with the manufacturer's written instructions will be marked on the container label...Activated chemical germicide is kept in an appropriately labeled, covered container...Clean the instruments as soon as possible after completion of the procedure...Organic matter should be pre-rinsed, cleaned with a enzymatic cleaner detergent, then rinsed and dried prior to terminal disinfection/sterilization...The item will be completely submersed in the chemical germicide solution for the appropriate amount of time as indicated on the instructions..."

7. An undated document provided by plant operations staff titled "Table 1 Environmental Controls" was reviewed and reflected that for ORs the temperature should be 68-73 degrees Fahrenheit and humidity 30-60 percent; for postanesthesia care units the temperature should be 70-75 degrees Fahrenheit and humidity 30-60 percent; and for "Storage areas" the temperature was "Not designated" and the humidity was 70 percent maximum.

Automated humidity logs provided by plant operations staff titled "history: LDH_AHU1/OR Average Humidity" was reviewed and was unclear and incomplete. The log had four columns titled Timestamp, Trend Flags, Status, and Value (percent). The "Timestamp" column listed only 22 dates from 04/14/2014 through 07/07/2015 with corresponding humidity levels recorded, a time frame of more than one year. The documentation was unclear related to what area(s) were being monitored. In addition, on 05/07/2015, the Status column reflected "(unackedAlarm)" and on 07/07/2015 the "Status" column reflected "(alarm, unackedAlarm)." There was no documentation to reflect what those entries represented or any follow up actions related to the recorded alarms.

During an interview conducted on 07/09/2015 at 1305, the OR manager/IC RN stated that the CAH had no policies and procedures for monitoring temperature and humidity levels in the surgical services department. The manager stated he/she had no documentation of temperature and humidity monitoring in the surgical services department and stated "Maintenance does that."

8. On 07/08/2015 at 1700, in the "Phase 2" clinic, where the CAH commenced provider-based outpatient services on 07/01/2015, the autoclave room was observed with the CRM. The autoclave had multiple sterile packs inside it that were dated 07/07/2015, and an open tray of metal speculums on top of it. It was unclear why the items were stored in those locations, and whether the speculums had been cleaned or disinfected. An undated document titled "Autoclave Instructions" was observed affixed to the wall with tape above the autoclave. The document reflected the following instructions: "Pour distilled H20 into machine; Turn to fill with door open until water reaches the plate; Turn to sterilize; Shut door set timer for 15 minutes; Make sure pressure is built up (green zone); Turn timer to 30 minutes; After 30 minutes turn to vent & drain." Another undated document titled "Sterilization Recommendations" was observed posted on the wall above the autoclave. The document contained recommendations for various sterilization methods, and reflected "Consult device manufacturer's and sterilizer manufacturer's recommendations." There was no documentation to reflect that the instructions were in accordance with manufacturer instructions, based on nationally recognized infection control practices or guidelines, and had been approved by the CAH.

An undated metal container with white liquid in it was observed on the counter top next to the autoclave. An undated document titled "Milk Bath Recipe" observed posted on the autoclave above the container reflected the following: "2 oz Lubricant Solution 12 oz Distilled Water." The lid on the container had a piece of paper taped to it with information related to hazardous waste and chemical exposure. There were no additional instructions related to the use of the "Milk Bath," and no documentation to reflect that the "recipe" was in accordance with manufacturer recommendations and had been approved by the CAH for use.

In addition, multiple open, undated, unlabeled, illegibly labeled and soiled gallon containers of chemicals, disinfectants and unknown liquids were observed in the cabinet under the sink located next to the autoclave.

During an interview with the OR manager/IC RN conducted on 07/09/2015 at 1315, the following information was requested and was not received: Manufacturer instructions, policies and procedures, and documentation related to operating and monitoring the autoclave in the Phase 2 provider-based clinic; and policies and procedures related to cleaning and disinfecting instruments used in the Phase 2 provider-based clinic. An email received from the OR manager/IC RN dated 07/13/2015 at 1154 confirmed the lack of the policies and procedures.

9. On 07/07/2015 at 1300 in the Radiology Department the following observations were made:
* Fix-Rite 2 Pump product had an expiration date of 06/2013.
* ThinPrep CytoLyt Solution had an expiration date of 04/27/2013.
* Multiple Povidone Swabsticks had expiration dates of 09/2013 and 06/2014.
* Boxes of Latex and Latex-Free Gloves had expiration dates of 12/2004 and 04/2014.
* Bard Max-Core Disposable Core Biopsy Instrument had an expiration date of 11/2014.
* Five Bard TruGuide Disposable Coaxial Biopsy Needle had expiration dates of 11/2014 and 06/2015.
* Two containers of Revital-Ox Resert Solution Test Strips had an expiration date of 03/29/2015.
* Five, one-liter bottles of Revital-Ox Resert Solution had an expiration date of 06/01/2015.
* Purell hand sanitizer had an expiration date of 12/2013.
* A large bulk container of MediChoice Ultrasound Gel was observed along with a number of smaller squeeze bottles labeled as ultrasound gel. Some of those secondary containers were MediChoice manufacturer's bottles. Other secondary containers were Parker Aquasonic 100 manufacturer's bottles. During interview with the Radiology Director at the time of the observation, he/she confirmed that all the secondary containers were filled with the product from the MediChoice bulk container.

10. On 07/07/2015 at 1430 in "Phase 3" clinic space the following observation was made:
* Five V.A.C. Therapy Simplace wound dressings had expiration dates of 02/16/2010 and 08/2013.

11. On 07/07/2015 at 1440 in the Sleep Lab the following observations were made on the shelves in a small utility closet above a deep sink. The width of the closet extended slightly beyond the width of the deep sink:
* Two gallons of vinegar were marked with "[best by]" dates of 09/09/2013 and 10/11/2013. The use for the vinegar was not clear.
* A coffee mug was observed half full of a clear liquid located near an open gallon container of isopropyl rubbing alcohol. The liquid smelled strongly of rubbing alcohol when sniffed. The CRM who was present during the observations confirmed that the liquid was rubbing alcohol.
* Two plastic baggies contained an assortment of various motel soaps and shampoos with a handwritten note attached that indicated they were donated for patient use. It was not clear if the use of patient care supplies, received from other than approved suppliers, was approved.
* An uncovered toothbrush was lying unprotected on the shelf.
* Two Nihon Kohden Neurofax machines were hanging from hooks immediately above the deep sink. Numerous wires and leads were hooked into the machines with electrodes at the ends and were dangling from the machines above the sink.
* A blue bucket contained multiple bags of leads and supplies for sleep lab machines was stored directly above the deep sink.

12. On 07/08/2015 at 1045 observations in the "Phase 1" provider-based clinic included, but were not limited to, the following:
* Purell hand sanitizers had expiration dates of 01/2013 and 02/2013.
* 10% Neutral Buffered Formalin specimen containers had expiration dates of 05/2015.
* A hand tray of phlebotomy and injection supplies was stored under a sink with air disinfectants and was placed directly under the plumbing.
* A container of Cavi-Wipes had an expiration date of 05/2013.
* A number of casting supplies were outdated.

13. On 07/08/2015 at 1145 observations in the "Phase 2" clinic, where the CAH commenced provider-based outpatient services on 07/01/2015, included:
* The "injection room" and the autoclave room were cluttered and disorganized. Old, outdated, and new drugs, supplies and miscellaneous items were co-mingled and packed every shelf, counter, and cabinet. The surfaces were covered with dirt, debris, and dried spills.
* A variety of supplies including: IV solutions, IV administration kits, IV extension kits, normal saline flushes, and scalp vein sets had expiration dates ranging between 01/2007 to 12/2013.

14. On 07/08/2015 at 1510 in the Cardiopulmonary Rehab Department and adjacent storage the following observations were made:
* A DeLee Mucus Trap had an expiration date of 03/2012.
* A Pedi Cap Co2 Detector had an expiration date of 06/2011.

15. During interview with the RT on 07/08/2015 at 1620 he/she stated that the alcohol observed in the coffee cup on 07/07/2015 at 1440 in the Sleep Lab was for "sterilizing" the electrodes on the "head box" also observed on 07/07/2015 at 1440 in the Sleep Lab. The RT stated he/she had been taught the cleaning process by another person and did not have manufacturer's instructions for cleaning the machines and electrodes. He/she stated that he/she didn't know what those manufacturer's procedures were and was working on policies and procedures. The RT stated that the director of another health system's sleep center had offered to share that system's policies and procedures.

During the interview the RT provided the other system's policy and procedure titled "[Health system name] Sleep & Neurodiagnostics Services...Cleaning and Disinfection of Equipment." At the top of the policy in bold was the following language: "Please refer to Infection Control Intranet site at each facility for general equipment cleaning and disinfection guidelines and policies." The procedure identified specific variances in the cleaning and disinfection process for at least five of that health system's multiple hospitals. The products identified in that policy and procedure included: Hepastat 256, Haemo-sol, collodion remover, Acetone, Ultraphene, bleach, and Sani-Cloth Plus wipes. The only reference to alcohol was in relation to "Airflow/Effort interface devices (boxes)...Prior to first use wipe with an isopropyl alcohol pad." There was section for "Nihon Kohden Nomad" devices in the policy and procedures. That section stipulated "...all external enclosure surfaces of the Nomad recorder and accessories will be cleaned with Sani-Cloth Plus...Connectors should not come in contact with liquid...All wires and probes will be cleaned with Sani-Cloth Plus..." The policy and procedure directed "Do not allow any of the connectors to be immersed in any water or solutions as this create a hazard and will damage the product and void the warranty."

A second policy and procedure titled "Premier Sleep Professionals...Polysomnographic sleep recording" dated as effective 04/01/2006 was also provided later during the survey. The section labeled "Post Test Procedures" contained inconsistent and contradictory information with the policy and procedure above. It directed "Disconnect patient electrodes and sensors removing majority of paste from hair...Decontaminate electrodes in ALCOHOL solution, rinse in clear water, and hang to air dry in clean utility."

16. During tour of the pharmacy on 07/09/2015 at 1015 a bottle with a dark solution in it was observed. The bottle did not have a manufacturer's label on it. A typewritten label was taped to the bottle and contained the following information: "Quaternary Disinfectant Cleaner." It contained a list of ingredients, an "Outdate" date, and the statement "For external use only."

On 07/09/2015 at approximately 1800 an unattended housekeeping cart was observed in the corridor outside of the cafeteria. It contained several bottles of solutions that were accessible and that did not have manufacturer's labels affixed to them. The only labels were typewritten as in the pharmacy example above. The typewriting on those labels identified the products as: "Quaternary Disinfectant Cleaner", "Isopropyl Alcohol 70% and Purified Water", "Beaucoup", and "Comet Bathroom Cleaner".

On 07/09/2015 at 1815 in a housekeeping closet, and on 07/10/2015 at approximately 0915 in the housekeeping department, original gallon-size manufacturer's containers for the housekeeping products were observed. All pertinent manufacturer's information and instructions on the gallon containers were not evident on the secondary containers observed in the pharmacy and the housekeeping cart. For example: The manufacturer's instruction on the gallon container of "Quaternary Disinfectant Cleaner" identified indications for use, reflected that the solution was "Hazardous...Wear protective eyewear...clothing...gloves", contained several specific first aid interventions in case of contact and had a phone number for "Emergency Medical information". The instructions stipulated that the containers were not to be refilled and described a specific process for cleaning and disposing of the containers. None of those pertinent instructions were on the secondary containers.

17. Refer to Tag C276, CFR 485.635(a)(3)(iv), regarding drug management, which reflects the CAH's failure to ensure multi-dose medication vials and other medications available for patient use were managed and stored appropriately and in accordance with CAH policies and procedures.

Based on interview, documentation in 15 of 22 medical records reviewed (Patients 5, 6, 7, 8, 10, 11, 12, 13, 14, 15, 17, 18, 19, 20, 21 and 22), review of policies and procedures and review of other documents, it was determined that the CAH failed to ensure that medical records were complete and accurate in the areas of:
* Patient's rights;
* Advance Directives; and
* Blood transfusions.

Findings include:

1. In the record of Patient 5, the "Conditions of Admission" consent form signed and dated by the patient's representative on 07/02/2015 included a checkbox for "Yes" and one for "No" next to an item that read "I have received a copy of the Patient Rights and Responsibilities." Neither the yes or the no box was checked.

In the record of Patient 12, the "Conditions of Admission" consent form signed and dated by the patient's representative on 07/06/2015 included a checkbox for "Yes" and one for "No" next to an item that read "I have received a copy of the Patient Rights and Responsibilities." The box next to "No" was checked and there was no documentation reflecting the reason the patient did not receive his/her Patient Rights.

Similar omissions and inconsistencies related to patient's rights documentation were identified in the records of Patients 6, 7, 8, 11, 13, 14, 15, 17, 18, 19, 20, and 22.

2. In the record of Patient 5, the "Conditions of Admission" consent form signed and dated by the patient's representative on 07/06/2015 included checkboxes for "Yes" and for "No" next to items that read "Do you have an Advanced (sic) Directive", "Have you received information concerning Advanced (sic) Directives when admitted previously?", "If information has not been received previously, packet was given." Neither the yes or the no box was checked for any of those items. However, the "Advance Directive" space on the "Record of Admission" form was recorded "N".

In the record of Patient 22, the "Conditions of Admission" consent form signed and dated by the patient's representative on 06/12/2015 was marked to reflect that "Yes", the patient had an Advance Directive. However, the "Advance Directive" space on the "Record of Admission" form was recorded "N".

Similar omissions and inconsistencies related to Advance Directive documentation were identified in the records of Patients 7, 8, 10, 11, 12, 14, 15, 17, 18, 19, 20, and 21.

3. The record of Patient 21 reflected that he/she was admitted as an inpatient on 05/08/2015 and received blood transfusions. The "Blood Transfusion Record" for the transfusion of blood unit W202115454762, started on 05/15/2015 at 1155, had blank spaces for "IV-Date/Time started", "Transfusion stopped Date", "Transfusion stopped Time", and "Total Volume Administered." The date and time blood unit number W202115454756 was signed out of the blood bank on the "Sign Out Record" was not recorded. In addition, the "Blood Transfusion Record" for the transfusion of that blood unit, started on 05/15/2015 at 1455, had blank spaces for "IV-Date/Time started", "Transfusion stopped Time", and "Total Volume Administered."

The record of Patient 20 reflected that he/she was admitted as an outpatient on 05/20/2015 and received blood transfusions. The "Blood Transfusion Record" was not used to document the provision of blood transfusions for Patient 20. Although most aspects of documentation about the transfusions were recorded in narrative form and other fields on the electronic record, there was no documentation that the blood units transfused on 05/20/2015, W202115437817001 and W202115446414003, had been subject to the two nurse (one RN and one RN or LPN) verification of the following information: "Consent form signed...Blood product verified with physician order...Pt. name, # on this form, wristband, tag on blood product are identical...Donor # and ABO/Rh types on this form and on product are identical...Product expiration date on this product has been checked."

The policy and procedure titled "Blood and Blood Product Administration Procedure", dated as revised on 08/12/2014, stipulated that the "Blood Transfusion Record" be used to document the provision of all steps of a transfusion. The policy and procedure included requirements that a specific, multi-step "Verification" process be conducted and documented on that form.

The record of Patient 19 contained findings related to blood transfusion documentation similar to those in the record of Patient 21 above.





29708

Based on observation and interview it was determined that the CAH failed to ensure the confidentiality of all patient medical record information. The CAH failed to provide safeguards against loss, destruction, and unauthorized access and use as patient medical records and information was observed in areas of the CAH that were not locked or secured and were accessible to unauthorized staff, patients, and visitors.

Findings include:

1. On 07/07/2015 at 1430 in "Phase 3" clinic space the following observation was made:
* A "Lake District Hospital Meaningful Use Stage 2 Stats" was lying on the work counter in an unlocked and unattended room. It contained 17 pages of patient names and patient information.

2. On 07/08/2015 at 1145 in the "Phase 2" clinic, where the CAH commenced provider-based outpatient services on 07/01/2015, the following observations were made:
* A large storage room was observed in a patient corridor. The door was opened and revealed numerous boxes of patient medical records that were not locked or secured.
* Multiple patient medical record files and loose patient records were lying unprotected and unsecured on an unattended counter in a patient corridor.