Brentwood Pediatrics

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 record review and interview with Testing Personnel #1, the laboratory failed to retain its Beckman Coulter AcT Diff hematology quality control and function check documentation at least two years for two (September and October 2022) of 12 months reviewed. Findings include: 1. A review of the laboratory's Beckman Coulter AcT Diff hematology quality control and background count records revealed a lack of documentation between 9/25/22 and 10/31/22. 2. An interview on 9/25/24 at 1:58 pm with Testing Personnel #1 confirmed the laboratory failed to retain documentation of its Beckman Coulter AcT Diff hematology quality control and function checks for at least two years. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to perform and document background checks for the Beckman Coulter AcT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Diff analyzer for February 1, 2023 to February 27, 2023. Findings include: 1. A review of the laboratory's Beckman Coulter AcT Diff hematology background count records revealed a lack of performance of background counts from 2/1/23 to 2/27/23. A total of 129 patients received testing on dates without background counts performed. 2. An interview on 9/25/2024 at 3:00 pm with TP1 confirmed that background checks were not performed and documented in the timeframes listed above. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview with Testing Personnel #1 (TP1), laboratory failed to conduct 6-month Calibration on the Beckman Coulter AcT Diff Analyzer for 2 (March 2023 and June 2024) of 4 events required for 2023 and 2024 Findings include: 1. Record review of the laboratory's Beckman Coulter's ACT Diff Analyzer calibration documentation revealed that the 6-month calibration verification had not been performed and documented at least every six months due March 2023 and June 2024. 2. An interview on 9/25/2024 at 3:00 pm with TP1 confirmed that calibration was not performed and documented in the timeframes listed above. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview with Testing Personne l (TP1)1, the laboratory failed to perform control procedures for the Beckman Coulter AcT Diff Analyzer for February 1, 2023 to February 27, 2023. Findings include: 1. A review of the laboratory's Beckman Coulter AcT Diff hematology quality control records revealed a lack of performance of control procedures from 2/1/23 to 2/27/23. A total of 129 patients received testing on dates without controls performed. 2. An interview on 9/25 /2024 at 3:00 pm with TP1 confirmed that quality control was not performed in the timeframes listed above. 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 observation, record review, and interview, the Laboratory Director failed to ensure 6-month Calibrations on the Beckman Coulter AcT Diff Analyzer were performed (Refer to D6020A), failed to ensure control procedures for the Beckman Coulter AcT Diff Analyzer were performed (Refer toD6020B), failed to ensure quality assessment programs established were capable of identifying failures in quality as they occurred (Refer to D6022), and failed to ensure that background checks for the Beckman Coulter AcT Diff analyzer were performed and documented. (Refer D6023). D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: . A Based on record review and interview with Testing Personnel 1 (TP1), laboratory director failed to ensure 6-month Calibrations on the Beckman Coulter AcT Diff Analyzer were performed. (Refer to D5439) B. Based on record review and interview with Testing Personnel l (TP1), the laboratory director failed to ensure control procedures for the Beckman Coulter AcT Diff Analyzer were performed. (Refer to D5445) D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of -- 3 of 4 -- 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 the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1, the Laboratory Director failed to ensure quality assessment programs established were capable of identifying failures in quality as they occured for one (February 2023) of 12 months of quality control and function check records reviewed. Findings include: 1. A review of the laboratory's Beckman Coulter AcT Diff hematology quality control and background count records revealed a lack of performance of background counts and control procedures from 2/1/23 to 2/27/23. A total of 129 patients received testing on dates without background counts or controls performed. 2. A review of the laboratory's quality assessment records between September 2022 and September 2024 revealed a lack of documentation showing the errors of not performing background counts or controls were identified and no

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #1, the laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to perform quality control testing each day of patient testing for the hematology complete blood count test. Refer to D5445. 2. The laboratory failed to perform and document the function checks as required for the room temperature in the laboratory. Refer to D5431. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with Testing Personnel (TP) #1, the laboratory failed to perform and document the function checks as required for 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 3 -- room temperature in the laboratory for 20 (May 2021 through December 28, 2022) of 20 months of operation of the Beckman Coulter AcT diff hematology analyzer. Findings include: 1. A record review on 12/28/2022 at 11:34 am revealed a lack of documentation of the room temperature for 20 (May 2021 through December 28, 2022) of 20 months of operation of the Beckman Coulter AcT diff hematology analyzer. 2. When queried on 12/28/2022 at 11:34 am, TP#1 was not able to provide the surveyor the documentation to show the room temperature had been performed and documented. 3. An interview on 12/28/2022 at 11:34 am, TP#1 confirmed the laboratory failed to perform and document the room temperature function checks for the proper operation of the Beckman Coulter AcT diff hematology analyzer. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #1, the laboratory failed to perform quality control testing each day of patient testing for the hematology complete blood count test for 2 days (8/30/2022 and 8/31/2022) of 20 months of testing reviewed. Findings include: 1. A record review of the laboratory's quality control documentation for the hematology complete blood count test using the Beckman Coulter AcT diff analyzer revealed a lack of documentation for testing performed on 8/30/2022 and 8/31/2022. 2. A record review for 2 days of 20 months of testing revealed the following: a. 8/30/2022 - 8 patients tested b. 8/31/2022 - 4 patients tested 3. An interview on 12/28/2022 at 9:45 am, TP#1 confirmed the laboratory did not have documentation of quality control performed on the dates listed above when patient testing was reported. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #1, the laboratory failed to ensure the testing personnel performing the duties of a Technical Consultant, had met the qualification requirements at 493.1411. Findings include: 1. The laboratory failed to ensure personnel performing the Technical Consultant duty of performing testing personnel competency assessments was qualified. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS -- 2 of 3 -- CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: . Based on record review and interview with the Testing Personnel (TP) #1, the laboratory failed to ensure personnel performing the Technical Consultant duty of testing personnel competency assessments was qualified for 2 (TP#1 and TP#2) of 2 personnel performing competency assessments. Findings include: 1. A review of the laboratory's personnel competency records revealed for 2 (TP#1 and TP#2) of 2 personnel performing competency assessments were not qualified as a Technical Consultant as follows: a. TP#1 tested by TP#2 b. TP#2 tested by TP#1 c. TP#3 tested by TP#1 d. TP#4 tested by TP#1 2. The surveyor requested the qualifications of TP#1 and TP#2 to serve as the Technical Consultant on 12/28/2022 at 9:45 am and the documentation was not made available. 3. An interview on 12/28/2022 at 9:45 am, TP#1 confirmed that TP#1 and TP#2 did not have the qualifications to perform the duties of a technical consultant. -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD) and Testing Personnel (TP) #2, the laboratory failed to enroll in a proficiency testing program for the mycology wet mount microscopic examination testing for 9 (8/11/2020 to 5/25 /2021) of 9 months. Findings include: 1. On 5/25/2021 at 11:07 am during a tour of the laboratory the surveyor identified a AmScope microscope on the countertop. 2. On 5/25/2021 at 11:43 am the surveyor requested a log for the wet mount examination testing, TP2 was unable to provide the documentation so a billing report was generated. 3. A record review of the billing report revealed for 9 (8/11/2020 to 5/25 /2021) of 9 months of testing 18 patients had wet mount testing performed. 4. A record review of the proficiency testing reports revealed a lack of documentation for the mycology wet mount testing. 5. An interview on 5/25/2021 at 11:43 am, the LD and TP2 confirmed the laboratory was not enrolled in a proficiency testing program and did not perform twice a year verification of accuracy for the wet mount examination. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with Testing Personnel (TP) #2, the laboratory failed to perform and document the function checks as required by the manufacturers for the room temperature for 2 (May 2019 to May 2021) of 2 years of operation for the hematology Beckman Coulter AcT diff instrument. Findings include: 1. A record review revealed lack of documentation of the room temperature for the proper operation of the Beckman Coulter AcT diff instrument for 2 (May 2019 to May 2021) of 2 years. 2. An interview on 5/25/2021 at 1:43 pm, TP2 was unable to provide the surveyor the documentation requested. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #2, the Technical Consultant (TC) failed to assure personnel performing wet mount examinations maintained their competency for 3 (TP1, TP7, and TP8) of 3 testing personnel performing the microscopic examination. Findings include: 1. A record review of the competency assessments revealed a lack of documentation for 3 (TP1, TP7, and TP8) of 3 personnel performing the wet mount preparations. 2. When queried on 5/25/2021 at 11:43 am, TP2 was unable to provide the surveyor documentation to show the testing personnel competency assessments had been performed and documented for the 9 months of performing wet mounts examinations. 3. An interview on 5/25/2021 at 11:43 am, TP2 confirmed lack of documentation for the competency assessments for TP1, TP7, and TP8. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: . Based on record review and interview with Testing Personnel #2 (TP2), the laboratory failed to provide the educational requirements for 2 (TP7 and TP8) of 8 testing personnel performing moderately complex testing. Refer to D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) -- 2 of 3 -- (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #2, the laboratory failed to ensure that all testing personnel met the educational requirements at 493.1423 for 2 (TP7 and TP8) of 8 testing personnel as listed on the CMS-209 performing moderately complex mycology testing. Findings include: 1. On 5/25/2021 at 11:43 am, record review for 2 of 9 testing personnel credentials revealed the educational requirements for performing moderately complex mycology testing was not met. 2. During the interview on 5/25/2021 at 11:43 am, TP2 as listed on the CMS- 209 confirmed the educational requirements were not met. 3. On 5/25/2021 at 11:43 am, the laboratory was given 7 additional days to supply the necessary educational documents. The documents were not received. -- 3 of 3 --

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 record review and interview with testing personnel #1 and #2 (TP1 and TP2), the laboratory failed to document the testing of the proficiency testing (TP) samples on the patient log sheet for the hematology complete blood cell count (CBC) for six (1st-3rd events 2017 and 2018) of six events reviewed. Findings include: 1. Record review of the American Proficiency Institute (API) final proficiency reports and the patient specimen log revealed the laboratory did not record the PT samples on the patient log sheet like routine patient samples for six of six testing events in 2017 and 2018. 2. During the interview on April 1, 2019 at 10:44 AM, TP1 and TP2 acknowledged the PT samples were not logged on the patient specimen log. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with testing personnel #1 and #2 (TP1 and TP2), the laboratory failed to ensure a written policy was established that included the competency requirements from subpart M for the hematology complete blood cell count (CBC) for five (TP1 - TP5) of five TP reviewed. Findings include: 1. Record review of the TP competency assessments revealed the laboratory did not establish and implement an assessment that contained the following six minimum regulatory requirements as follows: a. Direct observations of routine patient test performance, patient preparation, specimen handling, processing, and testing. b. Monitoring the recording and reporting of patient test results. c. Review of test results, worksheets, quality control records, proficiency testing results, and preventive maintenance. 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; and f. Assessment of problem solving skills. 2. Record review of the TP competency assessments revealed the laboratory did not perform and document competency assessments with the six requirements for five of five testing personnel from April 2017 to April 2019. 3. During the interview on April 1, 2019 at 10:15 AM, TP1 and TP2 acknowledged the competency assessments were not up to regulatory specifications. . 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 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require