Sfmg Pediatrics

Summary Statement of Deficiencies D0000 An Offsite revisit survey was conducted at Rosales Children's Clinic - CLIA ID #19D0971816 on February 7 laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories. No deficiencies were ci ________________________________________________________________________________________ A Certification survey was performed on November 29, 2023 at Rosales Children's Clinic, CLIA ID # 19D09 laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard leve were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integrat samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing records a with personnel, the laboratory failed to ensure testing personnel and laboratory director signed the attestation one (1) of six (6) proficiency testing (PT) events reviewed in 2022 and 2023. Findings: 1. Review of the labo American Association of Bioanalysts (AAB) proficiency testing (PT) records from 2022 and 2023 revealed th statements were not signed by the laboratory director and/or testing personnel for the following one (1) of six reviewed: a) AAB NonChemistry M2 2023: Laboratory Director and Testing Personnel did not sign attestatio interview on November 29, 2023 at 10:04 am, the laboratory supervisor confirmed the attestations were not s appropriate personnel as required. 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 doc maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 observation by surveyor, review of maintenance records, and interview with personnel, the laborato ensure the weekly maintenance on the Sysmex XP-300 was performed as required by the manufacturer. Find Observation by surveyor during the laboratory tour on November 29, 2023 at 09:15 am revealed the laborator Sysmex XP-300 analyzer for Complete Blood Count (CBC) testing in the specialty of Hematology. 2. Review laboratory's maintenance log for the Sysmex XP-300 hematology analyzer revealed the following weekly ma performed: a) Weekly: Clean SRV Tray 3. Further review of the maintenance records for the Sysmex XP-300 January 2022 through November 2023 revealed the laboratory did not perform the weekly maintenance for th three (3) of ninety six (96) weeks reviewed: a) November 10, 2023 b) November 17, 2023 c) November 24, 2 interview on November 29, 2023 at 10:24 am, the laboratory supervisor confirmed the weekly maintenance w performed for the identified weeks. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including employment of personnel who are competent to perform test procedures, and record and report test results pro accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory dire (3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and This STANDARD is not met as evidenced by: Based on review of laboratory policy and records along with interview with personnel, the Laboratory Direct ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to ensu maintenance on the Sysmex XP-300 was performed as required by the manufacturer. Refer to D5429. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including employment of personnel who are competent to perform test procedures, and record and report test results pro accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory dire (4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate th performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Certification Survey was performed on November 22, 2019 at Rosales Children's Clinic, CLIA ID # 19D0971816. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to document remedial action for unacceptable Hematology scores. Findings: 1. Review of the laboratory's 2018 and 2019 Proficiency Testing (PT) results revealed the laboratory received the following unacceptable results: a) Q2 Nonchemistry 2019: HMDD Erythrocytes - Module D Sample 2 - 80% b) Q2 Nonchemistry 2019: HMDD Hematocrit - Module D Sample 2 - 80% c) Q2 Nonchemistry 2019: HMDD Hemoglobin - Module D Sample 2 - 80% 2. Further review of PT records revealed the laboratory did not have any documentation of

Summary Statement of Deficiencies D0000 A Recertification Survey was performed at Rosales Children's Clinic - CLIA # 19D0971816 on January 10, 2018. Rosales Children's Clinic was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 42 CFR 493.1421 CONDITION: Laboratories Performing Moderate Complexity Testing; Testing Personnel D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it documents all complaints and problems reported to the laboratory. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the manual did not include written policy or procedure detailing how the laboratory is to address, document, and handle complaints or problems reported to the laboratory. 2. Interview with Personnel 1 and 2 on January 10, 2018 revealed they were unaware of all the policies and procedures that were required. Personnel 1 and 2 confirmed the laboratory did not have a complete policy and procedure manual. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an 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 -- authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it documents all complaints and problems reported to the laboratory. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 2. Interview with Personnel 1 and 2 on January 10, 2018 revealed they were unaware of all the policies and procedures that were required. Personnel 1 and 2 confirmed the laboratory failed to have a complete policy and procedure manual. 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 laboratory policy and procedure manual, and interview with personnel, the laboratory failed to establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to establish written policies and procedures that include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel involved in any phase of laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. Interview with Personnel 1 and 2 on January 10, 2018 confirmed the laboratory failed to have a detailed written policy and procedure that included the six (6) mandated items. 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 review of the laboratory's policy and procedure manual and interview with -- 2 of 6 -- personnel, the laboratory failed to establish a laboratory policy and procedure manual that contained complete policies and procedures. Findings: 1. Review of the laboratory policy and procedure manual revealed the laboratory failed to have policies and procedures for: Proficiency Testing (PT): a) Ordering and ensuring that you are enrolled for Proficiency Testing. b) What to do when you receive samples from the PT Provider. c) How to handle the samples; who will test, when to test, how do you assure no inter and intra laboratory communication takes place d) How to record results to send into the PT Provider to be scored. e) What records to maintain. f) How to evaluate when you receive your scores from the PT Provider. g) what steps to take if