Century Airport Pediatrics Pc

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 review of Standard Operating Procedures (SOPs), waived test manufacturer's package inserts, lack of temperature and humidity records, as well as interview with the Laboratory Director (LD), the laboratory failed to monitor, document temperature and humidity in the areas where waived test kits were stored, patient specimen processing occurred, and waived testing was performed. FINDINGS: 1. All waived test kit manufacturer's specifications specified temperature and humidity ranges for kit storage as well as patient specimen testing. 2. There was no monitoring, documentation of room temperature, humidity where waived test kits were stored, patient specimen processing occurred, and waived testing was performed. 3. The current, approved SOPs did not include instructions for performing such activity. 4. The LD confirmed the findings on November 20, 2024, at approximately 4: 30 P.M. 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 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation, review of SOPs and thermometer calibration records, as well as interview with the LD, the laboratory failed to perform and document thermometer calibration. FINDINGS: 1. The most recent calibration of the Fridge-Tag 2L thermometer, SN# 190500023706, utilized for monitoring temperatures of the throat and urine culture Lab-line Instruments incubator, was June 6, 2022. There was no documentation of thermometer calibration performance since the indicated June 9, 2024, expiration. 2. The most recent calibration of the Haier refrigerator Fridge-Tag 2L thermometer, SN# 190500023720, utilized for monitoring storage temperatures of bacitracin disks, blood agar plates, Kwik Stik Streptococcus agalactiae, and Streptococcus pyogenes microorganisms, was June 9, 2022. There was no documentation of thermometer calibration performance since the indicated June 9, 2024, expiration. 3. The current, approved SOPs did not include instructions for performing such activity. 4. The LD confirmed the findings on November 20, 2024, at approximately 4:30 P.M. D5781

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the ESA Lead Care II Quality Control (QC) records, analyzer manual and an interview with the testing person, the laboratory failed to follow the Magellan Diagnostic Lead Care manufacturer's QC requirement. FINDINGS: 1. The testing person confirmed on September 28, 2022, at approximately 10:30 AM, the laboratory did perform and document the QC results for Lead Care II Controls I & II for the following: a. Kit Lot # 053122 expiration date 2/19/2023- QC Lot # 2214M expiration date 02/17/2023 The control range for level II was 19.3-27.5 the recorded range was 28.0 b. Kit Lot # 053122 expiration date 2/19/2023- QC Lot # 2215M expiration date 02/28/2023 The control range for level I was 3.0-10.8 the recorded range was 11.4 2. Approximately 52 patient specimens were tested and reported from 8/15/2022 through 09/21/2022 when control results were out of range. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of competency assessment policy and an interview with the testing 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 -- person, the laboratory failed to follow their written competency evaluation policy for the two of six testing personnel. FINDINGS: 1. The laboratory's competency evaluation policy includes the six required components for competency assessment, including training, six-month for the first year of testing and annually thereafter. 2. The testing person confirmed on 9/28/22 at approximately 10:00 AM that the laboratory director failed to perform the annual competency evaluation for the two of six testing personnel in the calendar year 2021. Refer to D6054. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the Quality Assessment (QA) policy and an interview with the testing person, the laboratory failed to follow their establish QA policy and identify problems. FINDINGS: 1. The laboratory failed to follow their establish QA policy and identify the failure to perform annual competency evaluations on two of the six testing personnel, and out of range incubator temperature from 7/1/2021 through 12/31 /2021. 2. The laboratory testing person, confirmed on 9/28/2022 at approximately 11: 30 AM, the laboratory failed to follow their establish QA policy and identify problems on the 2021 QA document. Refer to D5413 and D6021 . 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 laboratory the incubator temperature records for the calendar years 2021 through survey date and interview with the testing person, the laboratory failed to follow the manufacturer's temperature requirement for throat culture and urine colony counts testing. FINDINGS: 1. The laboratory performs throat culture. The manufacturer of the throat culture media used for testing and the laboratory's temperature policy requires that the incubator temperature to be in the range of 35-38 degree Celsius. The laboratory converted to 95- 100.4 Fahrenheit. a. the testing personnel recorded the temperatures 100.7-101.4 F from 1/1/2021 through 12/31 /2021. 2. The incubator temperature was out of range for the following: 18 days in July 2021 29 days in August 2021 24 days in September 2021 20 days in October of 2021 2 days in November 2021 30 days in December 2021 3. Approximately 1,000 patients were tested for urine colony counts and throat cultures during the above dates 4. The testing person confirmed on September 28, 2022 at approximately 11:30 AM -- 2 of 3 -- that the the laboratory failed to follow the manufacturer's temperature requirement for throat culture and urine colony count testing. Refer D6021. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor's findings and an interview with the laboratory testing person, the laboratory director failed to provide overall management of the laboratory. FINDINGS: The laboratory director failed to ensure that the laboratory: 1. Maintained their written QA policy for all phases of laboratory testing, Refer to D6021; 2. Established competency assessment policy was followed, Refer to D6054. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's QA policy, 2021 QA documentation and an interview the testing person, the laboratory director failed to follow the establish QA procedure for having an ongoing mechanism to monitor, assess, and when indicated correct problems identified in the general laboratory system. Refer to D5209, D5291, D5413 and D6054. 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 the laboratory's competency assessment policy, lack of competency evaluations for two out of six testing personnel and confirmed in an interview with the laboratory testing person, the laboratory director, acting as the technical consultant, failed to assess the two of the six testing personal in 2021 Refer to D5209 -- 3 of 3 --

Summary Statement of Deficiencies 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 surveyor's review of the American Proficiency Institute (API) Proficiency Testing (PT) records and confirmed in an interview with the laboratory testing person, the laboratory failed to evaluate, perform and document the review of the PT Summary reports for all three test events in 2016 and the 1st and 2nd events of 2017. 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 surveyor's review of the API PT records, the lack of twice year verification documentation for urine colony counts and confirmed in an interview with the laboratory testing person, the laboratory failed to verify, at least twice annually, the accuracy of the urine colony counts for the calendar years 2016 and 2017. FINDINGS: The laboratory testing person confirmed on 1/30/2018 at approximately 2: 00 PM, that the laboratory failed to perform a twice year verification in calendar years 2016 and 2017 for the urine colony counts. PLEASE NOTE: THIS IS A RECITED DEFICIENCY FROM THE SURVEY OF JANUARY 27, 2016. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Assessment (QA) policy, QA 2016 and 2017 records, and confirmed in a interview with the laboratory testing person, the laboratory failed to follow their establish QA policy and identify issues and take