Gwu Medical Faculty Associates

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the testing person (TP), the lab director (LD) failed to attest that PT was performed in the same manner as patient testing when performing blood gas analysis. Findings: 1. Review of PT records on the day of the survey 10/29/24 at 2:00 PM showed that the LD did not review and sign the API Chemistry 3rd PT event performed on 9/10/24 nor the API Chemistry 2nd PT event performed on 6/4/24 2. Review of PT records on the day of the survey 10/29/24 at 2:00 PM showed the LD did not review and sign the API Chemistry 2nd and 3rd events performed in 2023. 3. The TP confirmed on the day of the survey 10/29/24 at 2:00 PM that the LD failed to attest that PT was performed in the same manner as patient testing when performing blood gas analysis. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based review of the written procedure manual and interview with the testing person (TP), the lab failed to maintain all internal quality control (QC) records. Findings: 1. The lab failed to retain the blood gas analyzer internal QC reports when QC failures occurred, since the last survey performed in 2022. 2. The blood gas analyzer performs an internal QC check every thirty minutes. 3. The blood gas analyzer failed internal QC on 7/30/24. 4. The TP stated on the day of the survey 10/29/24 at 2:00 PM that when the sensor and solution pack fail the QC check the analyzer is shut down. He will then complete the manufacturer "credit request form" to get a replacement solution pack. Once the request is completed and sent to the manufacturer all documentation is thrown away. 5. The "Retention of Documents" procedure states that the lab will retain all QC and calibration records in the QA notebook for two years. 6. The TP confirmed on the day of the survey 10/29/24 at 2:00 PM that the lab failed to retain the blood gas analyzer internal QC reports when QC failures occurred, since the last survey performed in 2022. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the testing person (TP), the lab failed to document temperatures for all areas of the lab. Findings: 1. The lab did not document the room temperature when performing blood gas analysis since the last survey in the 2022. 2. Review of the manufacturer specifications for the blood gas analyzer states that the optimal temperature range for the sensor cassette and the solution pack storage is between 5-25 Degrees Celsius and the optimal operating temperature range for the analyzer is between 12-28 Degrees Celsius. 3. The TP confirmed on the day of survey 10/29/24 at 2:30 PM that the lab did not document the room temperature when performing blood gas analysis since the last survey in 2022. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based review of the written procedure manual and interview with the testing person, the laboratory failed to document the expiration dates of hematology reagents and quality control materials. Findings: 1. The laboratory failed to document the expiration dates of the arterial blood gas reagent cassettes, solution packs, and quality control materials since the last survey in the year 2022. 2. The "Installation and Cleaning procedure" states that the lab will maintain a record of all cassette, solution packs, and the record will be maintained for two years. 3. The testing person confirmed on the day of the survey 10/29/24 at 1:00 PM that the expiration dates of hematology reagents and quality control materials was not documented since the last survey in year 2022. D5419 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(e) Components of reagent kits of different lot numbers must not be interchanged unless otherwise specified by the manufacturer. This STANDARD is not met as evidenced by: Based review of the written procedure manual and interview with the testing person, the laboratory failed to document the lot numbers of hematology reagents and quality control materials. Findings: 1. The laboratory failed to document the lot numbers of the arterial blood gas reagent cassettes, solution packs, and quality control materials since the last survey in the year 2022. 2. The "Installation and Cleaning procedure" states that the lab will maintain a record of all cassette, solution packs, and the record will be maitained for two years. 3. The testing person confirmed on the day of the survey 10/29/24 at 1:00 PM that the lot numbers of hematology reagents and quality control materials was not documented since the last survey in the year 2022 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the testing person, the laboratory failed to document the cleaning and disinfections of the blood gas analyzer. Findings: 1. The laboratory did not document the cleaning and disinfections of the blood gas analyzer every 30 days since the last survey in the year 2022. 2. The "Installation and Cleaning" procedure states that the lab will keep a log of the cleaning and disinfections of the blood gas analyzer and the record will be maintained for two years. The "Retention of Documents" procedure states that maintenance records will be kept in the QA book for two years. 3. The testing person confirmed on the day of the survey 10/29/24 at 1:00 PM that the lab failed to document the cleaning and disinfections of the blood gas analyzer every 30 days since the last survey in the year 2022. D5781

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on the review of Radiometer instructions (the manufacturer of calibration solution for ABL80 CO-OX machine), the laboratory's procedure for the tests performed in this laboratory, and confirmation by interview with the Testing Personnel, the laboratory failed to develop a temperature monitoring mechanism for the storage of the calibration solution for ABL80 CO-OX machine. The findings included: 1. Review of the manufacturer's instructions for ctHb calibration solution revealed instructions to store the solution for 24 months at 2-25 degrees centigrade (C) and for up to 14 days at a temperature up to 32C. In addition, the manufacturer further provide instructions to store the ampoules at a constant temperature between 18C and 32C for 5 hours before use. 2. Review of the laboratory's policies and procedures manual did not include a temperature monitoring for storage of ctHb calibration solution. 3. According to interview with the Testing Personnel, on 9/13/18 at approximately 1:30 PM, although there is a wall thermometer in the calibration storage room, the temperature is not monitored or documented. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on interview with Testing Personnel (TP) and representative of the proficiency test provider and review of the laboratory's proficiency testing (PT) results from the American Proficiency Institute (API), the Laboratory Director (LD) failed to ensure that the laboratory is re-enrolled in a timely manner to participate in a PT for Hemoglobin for one (1) testing event in 2018 (first testing event). The findings included: 1. Review of PT results from API (the laboratory's proficiency testing provider) for 2018 revealed that the laboratory did not participate in the PT for Blood gas and Blood Oximetry for the first testing event for lack of re-enrolment. 2. Interview with the TP on 9/13/18 at approximately 3:00 PM revealed that the laboratory did not re-enroll in API in a timely manner for 2018 due to miscommunication with API. Further interview with the TP revealed that the laboratory requested to cancel the third testing event in 2017 due to the staff traveling out of the country. The TP was under the assumption that re-enrollment was automatic. Although the laboratory obtained remedial sample for Blood Gas, was unable to get remedial sample for Blood Oximetry (that included hemoglobin). 3. Telephone interview with API representative on 9/21/18 (post the exit conference) confirmed that API did not send notice to the laboratory to enroll for 2018. According to API representative, the laboratory notified API that testing Blood Gas and Blood Oximetry test was to be discontinued on 8/27/17 and did not specify when the testing will resume. Further interview with API representative revealed that the laboratory requested for remedial sample for Blood Gas and Blood Oximetry on 4/10/18. API sent samples for Blood Gas but not for Blood Oximetry. According to the representative for API, samples for Blood Oximetry were unavailable on 4/10/18. -- 2 of 2 --