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Based on staff interviews and document review, the facility failed to ensure Punjabi-speaking patients were informed of their rights and received admission documents in their native language. This had the potential to deny patients their right to such information which could prevent them from making informed choices and advocating for their care.

Findings:

During an interview and concurrent document review on 6/11/15 at 9:22 a.m., Ancillary Staff AA was asked about the patient admission process. She stated she verified the patient's name, address, insurance carrier, reviewed the Conditions of Admission consent form, and gave them a, "pass code," for receiving their patient information, as well as a copy of their Medicare rights and HIPAA (Health Insurance Portability and Accountability Act) privacy rules. When asked if the information was printed in languages other than English, Ancillary Staff AA stated they are also printed in Spanish. For patients speaking other languages, she stated, if the patient arrived without English-speaking family, she utilized the AT&T interpreter phone line to convey the admission information. Regarding the Conditions of Admission consent form, Ancillary Staff AA stated she did not read the entire consent form, but rather summarized 4 of the 13 items through the interpreter phone line (Legal Relationship Between Hospital and Physicians, Financial Agreement, Advance Directive, and Personal Belongings).

During an interview on 6/11/15 at 9:35 a.m., Ancillary Staff BB was asked about the information given to non-English speaking patients. She stated the Medicare rights were available in English, Spanish, and Hmong. When asked about the Punjabi language, she stated she was able to speak Punjabi, but was only allowed to communicate and obtain basic information to/from these patients, such as name, date of birth, insurance carrier, etc. When asked about the size of the local Punjabi-speaking population, Ancillary Staff BB described it as, "good size."

Review of facility-provided statistics regarding patient languages for the two counties served by the facility indicated in July 2012:
In County A (Sutter)--0% spoke Hmong and 6.4% spoke Punjabi
In County B (Yuba)--2.1 % spoke Hmong and 0.1% spoke Punjabi

Review of the information provided to English-speaking patients upon admission found it to include: Your Right to Make Decisions About Medical Treatment, Patient Rights, Advance Directives, contact information for the Physical Therapy Board of California, and the facility's Financial Assistance Programs. Review of the information provided to Spanish-speaking patients found it to include Patient Rights and Your Right to Make Decisions About Medical Treatment. The facility did not provide to the surveyor any information printed in Hmong or Punjabi.

Based on interview and record review, the hospital failed to ensure that all information related to the patient assessment by licensed staff was recorded in the medical record for two of two patients (Patient 51 and Patient 52) requiring telemetry monitoring. Failure to effectively evaluate telemetry monitoring strips may result in delayed intervention, further compromising clinical status.

Findings:

1. Patient 51's face sheet, dated 6/8/15, and timed 3:08 a.m., indicated he was an 73-year-old patient receiving nursing care on 4 Main medical/telemetry nursing unit for symptomatic neutropenic fever (abnormally low count of neutrophils, a type of white blood cell that helps fight off infections) requiring telemetry monitoring. (Telemetry is a method of remotely monitoring cardiac rhythm via a portable unit to a central display terminal).
Patient 51's telemetry strip posted on the Telemetry Log dated, 6/9/15 at 7:41 a.m., indicated incomplete documentation. The telemetry strip lacked a date, time and staff signature, per the policy.

Patient 51's telemetry strip posted on 6/10/15 at 6:55 a.m., indicated incomplete documentation. The telemetry strip lacked a date, time and staff signature, per the policy.

Patient 51's telemetry strip posted on 6/10/15 at 7:41 p.m., indicated incomplete documentation. The telemetry strip lacked a date, time and staff signature, per the policy.

During an interview on 6/11/15 at 3 p.m., Administrative Staff S confirmed Patient 51's telemetry strips posted did not include a review and documentation by the registered nurse.

2. Patient 52's face sheet, dated 6/9/15, and timed 2:07 p.m., indicated he was an 60-year-old patient receiving nursing care on 2 West medical/telemetry nursing unit for ascites (the accumulation of fluid in the abdominal cavity, causing abdominal swelling) requiring telemetry monitoring. (Telemetry is a method of remotely monitoring cardiac rhythm via a portable unit to a central display terminal).

Patient 52's telemetry strip posted on the Telemetry Log, dated 6/11/15 at 4:22 a.m., indicated incomplete documentation. The telemetry strip lacked a date, time and staff signature, per the policy.

During an interview on 6/11/15 at 2:30 p.m., Administrative Staff S confirmed Patient 52's telemetry strips posted did not include a review and documentation by the registered nurse.

The facility policy and procedure titled, "Telemetry Monitoring - Nursing (v4)," dated 10/29/14, last review, indicated, "Purpose: To provide safe consistent care and early recognition of cardiac dysrhythmias to the patient requiring continuous telemetry monitoring....F. Primary care nurse is to assess the daily rhythm strip. Nurse is to date, time, and sign this strip and document in the medical record as stated above..."

Based on observation, interview, and review of records, the hospital failed to ensure Pharmaceutical Services staff followed hospital policy and procedure for Sterile Compounding and adhered to the United States Pharacopeial Standards Chapter 797 (USP<797>), which establishes standards for making Compounded Sterile Products (CSPs) such as intravenous (IV) solutions when:

1. Posted directions for garbing were not in correct order, as specified in the hospital policy for garbing or with USP<797> at Hospital MM.

2. No instrument was available for cleaning under the fingernails, as per the posted directions for garbing at Hospital MM.

3. Direct air flow was blocked to the injection port during the compounding of a sterile intravenous solution at Hospital MM.

4. The hospital compounded medium risk intravenous solutions in a Sterile Compounding Area specified as a low risk compounding area at Hospital MM.

5. Air displacement was not measured across the line of demarcation between the ante-area and the buffer area at Outpatient Services PP.

6. A wheeled cart straddled the demarcation line between the ante-area and the buffer area at Outpatient Services PP.

7. No evidence was provided that the Compounding Aseptic Isolator (CAI), in use in the pharmacy, could be placed in a worse than ISO 8 environment at Hospital OO.

These deficient practices had the potential to result in microbial contamination of Compounded Sterile Products (CSPs).

Findings:

1 and 2. During an observation, on 6/8/15 at 3:08 p.m., in the ante-room of the sterile compounding room at Hospital MM, a sign hung on the wall above the sink. The sign was titled, CORRECT ORDER FOR GOWNING AND GARBING IN THE IV ROOM, and listed the steps for garbing. Garbing is the donning of personal protective equipment (PPE) to prevent microbial contamination of Compounded Sterile Products (CSP) by particles of skin shed by the compounding staff.

The CORRECT ORDER OF GOWNING AND GARBING...read as follows: 1. Put on shoe covers. 2. Put on hair cover. 3. Put on beard cover (if necessary) followed by mask. 4. Clean under fingernails.
5. Wash hands and arms to elbows. 6. Dry hands with low shedding wipes. 7. Apply alcohol based hand sanitizer and allow to dry. 8. Put on clean gown. 9. Put on sterile powder free gloves."

An implement for cleaning nails was not at the sink or available in the ante- room.

During an interview, on 6/10/15 at 11:05 a.m., the Director of Pharmacy stated there was usually a fingernail scrubber at the sink (in the ante-room).

USP <797> specifies the order of compounding garb and washing as: Shoe covers, head and facial hair covers, face mask, fingernail cleaning, hand and forearm washing and drying, non-shedding gown, hand cleansing with alcohol based product, let dry, sterile gloves.

USP<797> was reviewed with the Director of Pharmacy during an interview, on 6/10/15 at 11:08 a.m. The Director of Pharmacy agreed that #7 and #8 on the posted list in the ante room should be reversed to put on gown first and then the use of alcohol based hand scrub just prior to putting on sterile gloves.

Review, on 6/11/15 at 8:16 a.m., of the hospital policy and procedure titled, STANDARD OPERATING PROCEDURES FOR STERILE COMPOUNDING-PHARMACY (4), 2893, published 5/8/15, and received at 7:45 a.m. on 6/11/15, indicated the purpose of the policy was, "...ensure all compounded sterile preparations (CSPs) are prepared in a safe and accurate manner." Section IV PROCEDURE: C. "Personnel Cleansing and Gowning," documented the proper garbing procedure, "...don... uniform components in the following order: Shoe covers, hair covers and face mask. Hands and and arms up to elbows...washed with soap for at least 30 seconds. Next, knee-length coats...will be put on. 3. An alcohol based surgical hand scrub...will be applied to hands and allowed to dry prior to donning powder free sterile gloves," as opposed to the sign observed in the ante room on 6/8/15. The policy however, did not include the necessary direction to clean under the fingernails.

3. During an observation on 6/8/15 at 3:15 p.m., Pharmacy Technician H prepared two normal saline 100 milliliter (ml), bags for intravenous (IV), administration by adding 10 milliequivalents (meq) of Potassium Chloride (KCl) to each IV bag, under the laminar air flow hood.

A laminar air flow hood is a workbench that is enclosed on all sides except the front. Air is drawn in the top of the workbench through a HEPA air filter (High Efficiency Particulate Assistance-the HEPA filter removes at least 99.7% of particles that have the size of 0.3 microns from the air). The air is then directed down the back and across the surface of the workbench toward the technician, pushing any remaining particulate matter out of the Direct Compounding Area (DCA). The laminar air flow hood provided an ISO Class 5 DCA within the hood.

International Organization for Standardization (ISO) classified air environments (specified by the numbers of particles in the air per cubic meter at a specified particle size), used for sterile compounding, decrease the risk of microbial contamination. An ISO Class 5 air environment has 3,520 particles, sized 0.3 microns or less per cubic meter of air. Outside, on the street, is an ISO Class 9 environment with 35 million particles sized 3 microns, in a cubic meter of air.

Pharmacy Technician H laid two bags of normal saline on the work surface, then opened the multidose vial of KCl. After drawing the first 10 meq of KCl up into a syringe, Pharmacy Technician H placed the bottle of KCl directly between first air (the air directly from the HEPA filter) and the injection port of one IV bag, which blocked the flow of clean air to the injection port, a critical site (A critical site is defined in USP<797> as a location that includes any components or fluid pathway surfaces exposed and at risk for direct contact with air).

Pharmacy Technician H acknowledged the obstruction of air flow, as the issue was discussed on 6/8/15, and discarded the prepared IV solutions.

Review, on 6/11/15 at 8:16 a.m., of the hospital policy and procedure titled, STANDARD OPERATING PROCEDURES FOR STERILE COMPOUNDING-PHARMACY (4), 2893, published 5/8/15, Section IV PROCEDURE D 15. indicated, "...supply items...are so arranged that a clear uninterrupted path of HEPA-filtered air will bathe the critical sites at all times during the planned procedures. That is, no objects may be placed behind an exposed critical site in a horizontal position or above in the vertical laminar flow workbench."

4. During an interview, on 6/8/15 at 3:15 p.m., Pharmacy Operations Manager JJ stated pharmacy services treated the compounding area in the pharmacy as a, "segregated compounding area" (SCA), as medications compounded there were considered, "low risk," and had Beyond Use Dates of 12 hours only. Pharmacy Manager JJ stated the SCA was also, "used occasionally," to compound TPN, a medium risk compound (TPN-Total Parenteral Nutrition, supplies amino acids, dextrose, essential fatty acids, electrolytes, vitamins in an IV form for those patients that cannot eat).

USP<797> defines compounding risk levels according to the potential for the introduction of contamination during the compounding process. Low Risk compounds are compounded in an ISO Class 5 air quality device, using sterile products, components and devices. Compounded products do not involve more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container.

Medium Risk Compounds are compounded in the same environment as low risk product and of sterile components, however Medium Risk products are compounded for multiple individual doses or multiple small doses that are pooled together to prepare one sterile compounded product and involve four or more sterile ingredients.

During an interview, on 6/8/15 at 4:16 p.m., the Director of Pharmacy described the use of a 10 gram vial of an antibiotic to make four separate doses for IV use and confirmed that the SCA was used for medium risk compounding.

5. and 6. During an observation on 6/10/15 at 3:30 p.m., at Outpatient Services PP Pharmacy, the medication sterile compounding area consisted of three attached rooms, closed off from the main pharmacy area. The compounding area was entered into an ante-room. To the right was a wide open doorway that led into a buffer area for a horizontal laminar air flow hood, used to make non-hazardous sterile compounded products. A stainless steel cart on wheels sat in the doorway, across the line of demarcation between the buffer area and ante-room, about six inches in the buffer area.

During an interview, on 6/10/15 at 1:32 p.m., Registered Pharmacist KK stated that the air displacement from the buffer area to the ante-room was measured every six months by a contracted certification service.

USP<797> states,"For buffer areas not physically separated from the ante-areas the principle of displacement airflow shall be be employed...Using displacement air flow typically requires an air velocity of 40 feet per minute or more from the buffer area across the line of demarcation into the ante-area...A velocity meter shall be installed to measure the...air flow between the buffer area and ante-area...the results shall be reviewed and documented at least every work shift (minimum frequency shall be at least daily)...differential airflow shall maintain a minimum velocity of ...40 feet per minute between the buffer area and the ante-area."

During an interview, at 2:01 p.m., the Director of Pharmacy stated the cart should be on one side or the other of the demarcation line. Registered Pharmacist KK stated she would move the cart to the left, into the anteroom.

Review of the hospital policy and procedure titled, STANDARD OPERATING PROCEDURES FOR STERILE COMPOUNDING-PHARMACY (4), 2893, published 5/8/15, indicated under IV D5: "Carts used to convey supplies in the clean area cannot be rolled beyond the demarcation line. If these carts are removed from the buffer area they cannot be re-entered unless cleaned and sanitized before returning."

7. During an observation on 6/11/15 at 12:15 p.m., in the pharmacy at Hospital OO, a Compounding Aseptic Isolator (CAI), sat against the far wall of the main pharmacy area. A red line of tape on the floor at the front and sides of the CAI designated an approximately three foot by six foot area as the buffer area.

Registered Pharmacist LL stated traffic was restricted in the area of the CAI when it was in use.

The CAI was a positive pressure glove box, divided into sections; an antechamber with a pass through to the main work chamber. Supplies were placed in the antechamber and the exterior door closed. With hands placed in, "robot gloves," the technician could then retrieve the supplies from the antechamber, bring them into the main work chamber via the pass through between the sections. A HEPA filter provided vertical laminar airflow.

Review, of the manufacturer's manual for the specific brand of CAI, indicated it was preferable that the CAI be located in an ISO Class 7 buffer air quality area. The manual did not document that the CAI could be placed in an ISO Class 8 or worse environment.

USP<797> directs that CAIs shall be located within a restricted access ISO Class 7 buffer area unless specific standards are met. USP<797> specifies that the compounding personnel should obtain documentation from the manufacturer that the CAI will meet these specific standards when placed in environments where the background particle counts exceed ISO Class 8 for 0.5 micron and larger particles.

Based on observation, interview, and review of records, the hospital failed to ensure Pharmaceutical Services staff followed hospital policy and procedure for Sterile Compounding and adhered to the United States Pharacopeial Standards Chapter 797 (USP<797>), which establishes standards for making Compounded Sterile Products (CSPs) such as intravenous (IV) solutions when:

1. Posted directions for garbing were not in correct order, as specified in the hospital policy for garbing or with USP<797> at Hospital MM.

2. No instrument was available for cleaning under the fingernails, as per the posted directions for garbing at Hospital MM.

3. Direct air flow was blocked to the injection port during the compounding of a sterile intravenous solution at Hospital MM.

4. The hospital compounded medium risk intravenous solutions in a Sterile Compounding Area specified as a low risk compounding area at Hospital MM.

5. Air displacement was not measured across the line of demarcation between the ante-area and the buffer area at Outpatient Services PP.

6. A wheeled cart straddled the demarcation line between the ante-area and the buffer area at Outpatient Services PP.

7. No evidence was provided that the Compounding Aseptic Isolator (CAI), in use in the pharmacy, could be placed in a worse than ISO 8 environment at Hospital OO.

These deficient practices had the potential to result in microbial contamination of Compounded Sterile Products (CSPs).

Findings:

1 and 2. During an observation, on 6/8/15 at 3:08 p.m., in the ante-room of the sterile compounding room at Hospital MM, a sign hung on the wall above the sink. The sign was titled, CORRECT ORDER FOR GOWNING AND GARBING IN THE IV ROOM, and listed the steps for garbing. Garbing is the donning of personal protective equipment (PPE) to prevent microbial contamination of Compounded Sterile Products (CSP) by particles of skin shed by the compounding staff.

The CORRECT ORDER OF GOWNING AND GARBING...read as follows: 1. Put on shoe covers. 2. Put on hair cover. 3. Put on beard cover (if necessary) followed by mask. 4. Clean under fingernails.
5. Wash hands and arms to elbows. 6. Dry hands with low shedding wipes. 7. Apply alcohol based hand sanitizer and allow to dry. 8. Put on clean gown. 9. Put on sterile powder free gloves."

An implement for cleaning nails was not at the sink or available in the ante- room.

During an interview, on 6/10/15 at 11:05 a.m., the Director of Pharmacy stated there was usually a fingernail scrubber at the sink (in the ante-room).

USP <797> specifies the order of compounding garb and washing as: Shoe covers, head and facial hair covers, face mask, fingernail cleaning, hand and forearm washing and drying, non-shedding gown, hand cleansing with alcohol based product, let dry, sterile gloves.

USP<797> was reviewed with the Director of Pharmacy during an interview, on 6/10/15 at 11:08 a.m. The Director of Pharmacy agreed that #7 and #8 on the posted list in the ante room should be reversed to put on gown first and then the use of alcohol based hand scrub just prior to putting on sterile gloves.

Review, on 6/11/15 at 8:16 a.m., of the hospital policy and procedure titled, STANDARD OPERATING PROCEDURES FOR STERILE COMPOUNDING-PHARMACY (4), 2893, published 5/8/15, and received at 7:45 a.m. on 6/11/15, indicated the purpose of the policy was, "...ensure all compounded sterile preparations (CSPs) are prepared in a safe and accurate manner." Section IV PROCEDURE: C. "Personnel Cleansing and Gowning," documented the proper garbing procedure, "...don... uniform components in the following order: Shoe covers, hair covers and face mask. Hands and and arms up to elbows...washed with soap for at least 30 seconds. Next, knee-length coats...will be put on. 3. An alcohol based surgical hand scrub...will be applied to hands and allowed to dry prior to donning powder free sterile gloves," as opposed to the sign observed in the ante room on 6/8/15. The policy however, did not include the necessary direction to clean under the fingernails.

3. During an observation on 6/8/15 at 3:15 p.m., Pharmacy Technician H prepared two normal saline 100 milliliter (ml), bags for intravenous (IV), administration by adding 10 milliequivalents (meq) of Potassium Chloride (KCl) to each IV bag, under the laminar air flow hood.

A laminar air flow hood is a workbench that is enclosed on all sides except the front. Air is drawn in the top of the workbench through a HEPA air filter (High Efficiency Particulate Assistance-the HEPA filter removes at least 99.7% of particles that have the size of 0.3 microns from the air). The air is then directed down the back and across the surface of the workbench toward the technician, pushing any remaining particulate matter out of the Direct Compounding Area (DCA). The laminar air flow hood provided an ISO Class 5 DCA within the hood.

International Organization for Standardization (ISO) classified air environments (specified by the numbers of particles in the air per cubic meter at a specified particle size), used for sterile compounding, decrease the risk of microbial contamination. An ISO Class 5 air environment has 3,520 particles, sized 0.3 microns or less per cubic meter of air. Outside, on the street, is an ISO Class 9 environment with 35 million particles sized 3 microns, in a cubic meter of air.

Pharmacy Technician H laid two bags of normal saline on the work surface, then opened the multidose vial of KCl. After drawing the first 10 meq of KCl up into a syringe, Pharmacy Technician H placed the bottle of KCl directly between first air (the air directly from the HEPA filter) and the injection port of one IV bag, which blocked the flow of clean air to the injection port, a critical site (A critical site is defined in USP<797> as a location that includes any components or fluid pathway surfaces exposed and at risk for direct contact with air).

Pharmacy Technician H acknowledged the obstruction of air flow, as the issue was discussed on 6/8/15, and discarded the prepared IV solutions.

Review, on 6/11/15 at 8:16 a.m., of the hospital policy and procedure titled, STANDARD OPERATING PROCEDURES FOR STERILE COMPOUNDING-PHARMACY (4), 2893, published 5/8/15, Section IV PROCEDURE D 15. indicated, "...supply items...are so arranged that a clear uninterrupted path of HEPA-filtered air will bathe the critical sites at all times during the planned procedures. That is, no objects may be placed behind an exposed critical site in a horizontal position or above in the vertical laminar flow workbench."

4. During an interview, on 6/8/15 at 3:15 p.m., Pharmacy Operations Manager JJ stated pharmacy services treated the compounding area in the pharmacy as a, "segregated compounding area" (SCA), as medications compounded there were considered, "low risk," and had Beyond Use Dates of 12 hours only. Pharmacy Manager JJ stated the SCA was also, "used occasionally," to compound TPN, a medium risk compound (TPN-Total Parenteral Nutrition, supplies amino acids, dextrose, essential fatty acids, electrolytes, vitamins in an IV form for those patients that cannot eat).

USP<797> defines compounding risk levels according to the potential for the introduction of contamination during the compounding process. Low Risk compounds are compounded in an ISO Class 5 air quality device, using sterile products, components and devices. Compounded products do not involve more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container.

Medium Risk Compounds are compounded in the same environment as low risk product and of sterile components, however Medium Risk products are compounded for multiple individual doses or multiple small doses that are pooled together to prepare one sterile compounded product and involve four or more sterile ingredients.

During an interview, on 6/8/15 at 4:16 p.m., the Director of Pharmacy described the use of a 10 gram vial of an antibiotic to make four separate doses for IV use and confirmed that the SCA was used for medium risk compounding.

5. and 6. During an observation on 6/10/15 at 3:30 p.m., at Outpati