Selma Pediatrics Pc

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Medonic Hematology analyzer calibration records, the Medonic User's Manual and an interview with the Laboratory Director, the laboratory failed to perform and document quality controls (QC) following calibration as per manufacturer's instructions. This was noted for two out of five calibrations performed from April 2022 to the date of the current survey, 10/25/2023. The findings include: 1. A review of the Medonic Hematology records revealed calibrations and QC as follows: A) Calibration 3/21/2023 at 07:39 AM with QC performed at 7:27 AM only. B) Calibration 10/20/2023 at 08:45 AM with QC performed at 07:30 AM only. 2. A review of the Medonic M Series User's Manual on page 62 in the Calibration Section revealed, "...17. It is recommended to run controls after calibration to verify that all parameters have been calibrated correctly. ...". 3. During an interview on 10/25/2023 at 3:30 PM, the above noted findings were reviewed and confirmed with the Laboratory Director. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES 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 -- CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview the Laboratory Director, the Technical Consultant failed to assess competency at least semi annually in the first year of patient testing for the Medonic M Series Hematology Analyzer. This was noted for one out of six new Testing Personnel since the date of the last survey, April 19, 2022, to the date of the current survey, October 25, 2023. The findings include: 1. A review of Personnel records revealed Testing Personnel #8 to have an initial training date of 2/20/23. No evidence of a six month competency assessment was available for review. 2. During an interview on 10/25/2023 at 3:30 PM, the Laboratory Director confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview with the Laboratory Director, the Technical Consultant failed to assess competency of Testing Personnel at least annually for the Medonic M Series Hematology Analyzer. This was noted for four out of seven Testing Personnel eligible for annual assessment from the date of the last survey, January 27, 2022, to the date of the current survey, October 11, 2023. The findings include: 1. A review of Personnel records revealed the following: A) Testing Personnel #1 had an annual competency assessment dated 1/7/2023 only. No evidence of an annual competency assessment for 2022 was available for review. B) Testing Personnel #2 had an annual competency assessment dated 1/7/2022 only. No evidence of an annual competency assessment for 2023 was available for review. C) Testing Personnel #4 had an initial training date of 7/27/2022 and a six month competency assessment dated 1/9/2023. No evidence of an annual competency assessment for 2023 was available for review. D) Testing Personnel #5 had an initial training date of 5/23/2022 and a six month competency assessment dated 1/23/2023. No evidence of an annual competency assessment for 2023 was available for review. 2. During an interview on 10/25/2023 at 3:30 PM, the Laboratory Director confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 on a review of the 2019 - 2022 Medonic M Series Hematology calibration records, and an interview with the Laboratory Director, the laboratory failed to retain the manufacturer's assay sheets (package insert) for one of seven calibrations reviewed. The findings include: 1. A review of the 2019 - 2022 Medonic M Series Hematology records revealed no manufacturer's assay sheet (package insert) for the calibrator utilized during the 10/15/2021 calibration of the instrument. 2. During the exit summation on 4/19/2022 at 4:00 PM, the above noted findings were reviewed and confirmed with the Laboratory Director. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of accuracy verification documentation for Fungal Cultures performed on ACU-DTM (Dermatophyte Test Medium) and an interview with the Laboratory Director, the surveyor determined the laboratory failed to verify the accuracy of Fungal Cultures the second half of 2019 and 2021. This was noted in two out of three years of accuracy verification records reviewed. The findings include: 1. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- A review of 2019-2021 accuracy verification records for Fungal Cultures performed on ACU-DTM revealed the laboratory performed "split sample" testing for "Growth" or "No Growth" with a reference laboratory, and compared the results twice a year. However, the surveyor noted records for only one accuracy verification comparison in 2019 (5/24/2019), and one in 2021 (4/20/2021). 2. During an interview on 4/19/2022 at 1:23 PM, the Laboratory Director confirmed the above noted findings. . 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 a review of environmental records, and an interview with the Laboratory Director, the laboratory failed to ensure temperature and humidity records were retained and accessible on the day of the survey. The laboratory was unable to locate 2019 and 2020 (two of four years) records for room temperature and humidity, and incubator temperatures. Monthly refrigerator temperature records (2019-2021) for the laboratory were mixed with general monthly records, and the laboratory was unable to collate and organize the records for review during the survey. The findings include: 1. A review of the poorly organized monthly records revealed the laboratory recorded room temperature and humidity, and incubator temperatures on one sheet annually, however the staff were unable to located the sheets for 2019 and 2020. The laboratory was unable to provide 2019-2020 documentation demonstrating the Medonic was operated within the manufacturer's environmental specification, or documentation of the urine and fungal culture incubation temperatures. 2. A review of temperature requirements for the Hematology controls and ACU-DTM (Dermatophyte Test Medium) revealed storage requirements of 2-8 degrees Celsius, or 35-46 degrees Fahrenheit. The laboratory used "Vaccine Logs" to document the temperatures in which these laboratory items were stored. These records were mixed with vaccine logs for three other refrigerators, and in folders with individual monthly records for 2019-2022. The surveyor requested the laboratory refrigerator temperatures, however the laboratory failed to provide these records during the survey period. 3. During the exit summation with the Laboratory Director on 4/19/2022 at 4:00 PM, the laboratory was unable to provide the above noted environmental records. The surveyor explained CLIA did not specify how a laboratory should store their records, however a laboratory should utilize a mechanism to allow accessibility to the records requested during the on-site survey. . D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) -- 2 of 3 -- Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Medonic Hematology analyzer calibration records, the Medonic User's Manual and an interview with the Laboratory Director, the laboratory failed to perform and document controls after two of two 2019 calibrations, as per manufacturer's instructions. The findings include: 1. A review of the Medonic Hematology records revealed calibrations and QC as follows: A) Calibration 9/24 /2019 at 08:12 AM with QC performed 7:26 to 7:28 AM only B) Calibration 12/5 /2019 at 10:57 AM with QC performed 8:38 to 8:40 AM only 2. A review of the Medonic M Series User's Manual on page 62 in the Calibration Section revealed, "... 17. It is recommended to run controls after calibration to verify that all parameters have been calibrated correctly. ...". 3. During the exit summation on 4/19/2022 at 4:00 PM, the above noted findings were reviewed and confirmed with the Laboratory Director. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of CAP (College of American Pathologists) proficiency testing records, a review of the personnel files and CMS form #209 (Laboratory Personnel Report), and an interview with the Laboratory Director (LD), who also serves as the Technical Consultant, the surveyor determined the laboratory failed to ensure proficiency testing was rotated amongst all testing personnel, who performed moderate complexity testing. This affected eight of eight Hematology testing events reviewed by the surveyor. The findings include: 1. A review of the CMS form #209 (the Laboratory Personnel Report) revealed eleven testing personnel. At 11:14 AM on June 20, 2019, the LD stated all personnel listed on this form tested moderate complexity (non-waived) tests, which included the CBC (Complete Blood Counts) on the Medonic. 2. A review of the personnel files revealed only three of the eleven personnel listed were considered new employees since the last survey (June of 2017), and the three were hired in 2019. 3. A review of the proficiency testing records revealed all of the attestation statements for Hematology testing events in 2017 (three events), 2018 (three events) and the first two events in 2019 were signed by Testing Personnel #1 (as the testing personnel). 4. In an interview on 6/20/2019 at 12:18 PM, the surveyor inquired about the performance of the proficiency testing. The LD stated [Testing Personnel (TP) #1] was a part-time employee, and because all of the other nurses were usually assigned, when TP #1 arrived at work, TP#1 was usually assigned to the laboratory. The LD further stated all the other nurses could participate in the proficiency testing, it had been a matter of convenience. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 a review of the CAP (College of American Pathologists) proficiency testing records, including the attestation statements, and an interview with the Laboratory Director (LD), who also serves as the Technical Consultant, the surveyor determined the Laboratory Director failed to sign the attestation statement for Hematology testing event FH2 A, 2019, one of fifteen testing events reviewed by the surveyor for 2017 - 2019. The findings include: 1. A review of the proficiency testing records revealed the LD did not sign the attestation statement for Hematology testing event FH2-A, 2019. 2. In an interview on 6/20/2019 at 12:18 PM, the LD confirmed he missed signing the attestation statement for the above mentioned event. The LD stated he believed this was the first event the laboratory submitted electronic proficiency testing results, rather than mailing the documentation. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's test menu, a review of CAP (College of American Pathologists) proficiency testing records, and an interview with the Laboratory Director (also the Technical Consultant), the surveyor determined the laboratory failed to review and evaluate the results for Microbiology Event MC3-A, 2017, due to the laboratory's failure to obtain the results from the proficiency testing provider. This affected one of seven Microbiology testing events reviewed by the surveyor. The findings include: 1. A review of the proficiency testing records for Microbiology MC3-A, 2017 revealed no result sheet or summary and no review or evaluation returned from CAP. 2. In an interview on June 20, 2019 at 12:11 PM, the Laboratory Director (LD) reviewed the laboratory's records and stated the results were faxed to CAP on April 3 (2017). The LD also confirmed the proficiency testing records did not include any results for the event. At 12:34 PM, after further investigation, the LD stated CAP indicated a code 40 for the laboratory, which meant no results were received by CAP from the laboratory. The LD failed to realize the results were never received by CAP, until the day of the survey. D5477 CONTROL PROCEDURES -- 2 of 5 -- CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Uricult and DTM (Dermatophyte Test Medium) Fungal Culture Quality Control (QC) records, a lack of documentation, and an interview with the Laboratory Director (LD), who also serves as the Technical Consultant (TC), the surveyor determined the laboratory failed to perform and document visual inspections of the Acu-DTM media. The laboratory further failed to perform quality control of the Uricult [CLED (Cystine-Lactose Electrolyte Deficient/EMB(Eosin Methylene Blue)] media to verify its ability to support growth and select or inhibit growth of bacterial organisms. The laboratory had not established any IQCP (Individualized Quality Control Plan). This affected the survey review period of July 2017 - June 20, 2019. This is a repeat deficiency. The laboratory failed to implement