Shaker Pediatrics Pc

Summary Statement of Deficiencies D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) 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. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) proficiency testing (PT) reports as well as interview with the Testing Personnel (TP), the laboratory failed to complete the attestation statement provided by the PT program, signed by the analyst and Laboratory Director (LD), documenting that PT samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the PT event. FINDINGS: 1. There was no documentation of TP and LD signature and date of signature on the CAP PT attestation statements for the third event of 2022 as well as the first, second, and third events of 2023 and 2024. 2. The TP confirmed the findings on March 5, 2025, at approximately 3:00 P.M. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of competency assessment records, Standard Operating Procedures (SOPs), as well as interview with the TP, the laboratory failed to perform and document TP training and competency assessment. FINDINGS: 1. There was no documentation of S.M. TP training and competency assessment for 2022, 2023, 2024, and 2025. 2. This is contrary to instructions included in the current, approved SOPs. 3. The TP confirmed the findings on March 5, 2025, at approximately 11:30 A.M. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 direct observations, review of SOPs, manufacturer's package inserts, lack of room temperature and humidity records, as well as interview with the TP, the laboratory failed to monitor and document ambient room temperature and humidity in the area where waived and non-waived test materials were stored, patient specimens processed, and testing performed. FINDINGS: 1. There was no documentation of ambient room temperature and humidity for the area where waived and non-waived test materials were stored, patient specimens processed, and testing performed. 2. No thermometer/humidistat was present in the area for monitoring ambient temperatures. 3. The current, approved SOPs did not include instructions for performing such activity. 4. The TP confirmed the findings on March 5, 2025, at approximately 2:30 P. M. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of personnel competency performance records, SOPs, as well as interview with TP, the LD failed to comply with current, approved policies to assure TP competency. Refer to D5209. -- 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 the review of the Uricult System Quality Control (QC) records for 2021 and 2022 and an interview with the laboratory testing person, the laboratory failed to retain the Uricult System Clinical Laboratory Standards Institute (CLSI) certificates for the calendar years 2021 and 2022. FINDINGS: 1. Review of the Uricult System QC records for the calendar years 2021 and 2022, the laboratory failed to retain the Uricult System CLSI certificates. 2. Testing person confirmed on August 4, 2022 at 10:30 AM that the laboratory failed to retain the Uricult System CLSI certificates. 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 the competency evaluation records for the calendar years 2020, 2021 and an interview with the testing person, the laboratory failed to follow their written competency evaluation policy for the one routine testing person for the calendar years 2020 and 2021. FINDINGS: The competency evaluation form currently in use to assess the testing person competency 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 -- failed to include the six criteria to evaluate the testing person. a. 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. The six required components are: 1. direct observation of routine patient test performance, including preparation. specimen handling and testing; 2. monitoring the recording and reporting of test results; 3. review of intermediate results of worksheets, quality control records, proficiency testing results, and preventive maintenance records; 4. direct observation of performance of instrument maintenance and function checks; 5. assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, 6. assessment of problem solving skills. 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 a interview with the testing person, the laboratory failed to follow their establish QA policy and perform a annual QA review for the calendar years 2020 and 2021. FINDINGS: 1. The laboratory to follow their establish QA policy and perform a annual QA review for the calendar years 2020 and 2021. a. 2020 and 2021 annual QA review documentation was not available for review. 2. The testing person confirmed on August 4, 2022 at approximately 11:00 AM, the laboratory to follow their establish QA policy. 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 temperature procedure for the incubator, the incubator temperature records for the calendar years 2020, 2021 through survey date and interview with the testing person, the laboratory failed to follow the manufacturer's temperature requiremenst 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 require that the incubator temperature to be in the range of 35-38 degree Celsius. 2. The incubator temperature was out of range for the following: 3 days in April 2020 @ 40C 17 days in December 2020 @ 40C January 1, 2021 through December 31, 2021 @ 40C January 1, 2022 through August 4, 2022 @ 40C 3. Approximately 1,500 -- 2 of 3 -- patients were tested for urine colony counts and throat cultures during the above dates 4. The testing person confirmed on August 4, 2022 at approximately 11:30 AM that the the laboratory failed to follow the manufacturer's temperature requiremenst for throat culture and urine colony count testing. 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 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, lack of 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 D5291 and D5413 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, competency evaluation form currently in use and and confirmed in an interview with the testing person, the laboratory director, acting as the technical consultant, failed to assess the testing person using the six criteria requirements. Refer to D5209 -- 3 of 3 --

Summary Statement of Deficiencies 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 the surveyor's review of the laboratory's Quality Assessment (QA) polices /procedures and an interview with and confirmed by the laboratory supervisor, the laboratory failed to follow the laboratory's written QA policy and perform general laboratory systems QA reviews yearly for bacteriology testing in calendar years 2016 and 2017. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Control Plan (QCP) for the bacitracin disks and confirmed in an interview with the laboratory supervisor, the laboratory personnel failed to follow the laboratory's QCP for bacitracin disks used for throat culture testing. FINDINGS: The laboratory supervisor confirmed on 01/26 /2018 at approximately 11:00 AM that the laboratory personnel did not follow the 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 -- established QCP for the bacitracin disks and perform quality control weekly using a positive and negative organism to check the reactivity of the disks. D5477 CONTROL PROCEDURES 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 the surveyors review of quality control (QC) records for Selective Strep Agar (SSA) used to throat culture testing and confirmed in an interview with the laboratory supervisor on 01/26/2018, the laboratory failed to check and document the physical characteristics of the SSA media and failed to perform the sterility check on each new batch (shipment) or lot number of SSA media in calendar years 2016, 2017 through to 01/26/2018. Approximately 500 patients throat culture tests were performed and read from 01/01/2016 through 01/26/2018. -- 2 of 2 --