Brentwood Pediatrics Pllc

Summary Statement of Deficiencies D0000 The Brentwood Pediatrics, PLLC laboratory was found not to be in compliance with the following CLIA conditions: D5024: 493.1250 Condition: Hematology D6000: 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D6033 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant 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 review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (Form CMS-209), proficiency testing records, and staff interview, the laboratory failed to ensure the proficiency testing samples were tested by personnel who routinely performed the complete blood count (CBC) patient testing in 2021 and 2022 for six of six events reviewed. The findings include: 1. Review of the Form CMS-209 survey revealed four testing personnel who routinely performed CBC patient testing. 2. Review of the American Proficiency Institute (API) proficiency testing (PT) attestation statements and instrument printouts for 2021 and 2022 revealed the following: 2021 events one, two and three were performed by a single testing person (no longer employed or listed on CMS-209) 2022 events one, two, and three were performed by testing person one listed on CMS-209 3. Interview with testing person one confirmed the laboratory failed to ensure all testing persons were included in the testing of proficiency testing samples for the events in 2021 and 2022. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- 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 review of the laboratory's quality controls (QC) records and staff interview, the laboratory failed to maintain manufacturer's QC package inserts for a period of two years for the Beckman Coulter AcT Diff and the Sysmex XP 300 instruments used to perform patient testing of complete blood counts (CBC) from April 2021 until January 23, 2023 for an approximate number of 18 lots used. This standard was previously cited from the survey on 10/04/2018 and determined that compliance was not maintained at the recertification survey on 04/14/2023. The findings include: 1. Review of the laboratory's QC records from April 2021 until the date of the survey on 04/14/2023 revealed the following: The Beckman Coulter AcT Diff was in use from April 2021 until December 3, 2021. The Sysmex XP 300 (serial C2411) was in use from December 6, 2021 until the date of survey 04/14/2023. 2. No package inserts were retained from April 2021 until January 23, 2023. 3. Review of the laboratory's QC correction log revealed the following Beckman Coulter AcT Diff lots used: 069800, 079800, 089800 03/11/20- 06/14/2021 067900, 077900, 087900 06/15/20- 09 /10/2021 068600, 078600, 088600 09/13/2021-12/03/2021 Review of the laboratory's QC instrument printouts from 12/06/2021 following calibration for Sysmex XP 300 (serial C2411) revealed lot numbers 13030710, 13060710, and 13060712 with expiration date of 02/09/2022 were used. 3. Interview with testing person one on 04/14 /2023 at 2:30 p.m. confirmed the laboratory failed to maintain manufacturer's QC package inserts for CBC quality controls for a period of two years in 2021, 2022, and 2023. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records and staff interview, the laboratory failed to retain all proficiency testing records for a period of two years in 2022. This standard was previously cited from survey on 10/04/2018 and determined that compliance was not maintained at the recertification survey on 04/14/2023. The findings include: 1. Review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records for Hematology/Coagulation revealed the attestation statement for 2022 event 2 was not included in the records for that event (one of six events reviewed for 2021, 2022, and 2023). 2. Interview on 04/14/2023 at 2:30 p.m. with testing person one confirmed the laboratory failed to maintain the attestation statement for 2022 event 2 for two years. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. -- 2 of 11 -- This CONDITION is not met as evidenced by: Based on record review and interview it was determined that the laboratory failed to ensure procedures for use for the Sysmex XP 300 (serial C2411) used for complete blood count (CBC) patient testing were approved (See D5407), failed to monitor room temperature and humidity where the Sysmex XP 300 was in use (See D5413), failed to perform a normal range study for the Sysmex XP 300 that was used on 12/05/2021 (See D5421), failed to have a quality control procedure in place to monitor precision and accuracy over a period of time (See D5441), failed to have an effective quality assessment process in place (See 5793), and failed to follow

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: =================================== Hematology: The laboratory failed to maintain satisfactory participation in two consecutive events for the Cell I.D. or WBC Diff analyte resulting in the initial unsuccessful proficiency testing (PT) occurrence for Cell I.D. of WBC Diff (Refer to D2130) =================================== D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: =================================== Based on a Proficiency Testing (PT) desk review of the CMS CASPER Report 0155D and the laboratory's 2022 Proficiency Testing (PT) performance summary records from the American Proficiency Institute (API) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the Cell I.D. or WBC Diff analyte in the 1st event 2022 and 2nd event 2022, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed unsatisfactory Cell I.D. or WBC Diff analyte scores of 7% for the 1st event of 2022 and 33% for the 2nd event of 2022. 2. A review of the laboratory's API Proficiency Testing records revealed unsatisfactory Cell I.D. or WBC Diff analyte scores of 7% for the 1st event of 2022 and 33% for the 2nd event of 2022, resulting in the intial unsuccessful PT occurrence. =================================== -- 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 review of the complete blood count (CBC) instrument quality control records and interview with Testing Person #3 determined that the laboratory failed to maintain the CBC instrument QC printouts when the results were not in range, for at least two years. The findings include: 1) Review of the CBC instrument quality control for Oct. 2017, Feb, 2018, June 2018, Aug. 2018, and Sept. 2018 did not reveal any quality control results that requested a repeat or were not in range. 2) Interview with Testing Person #3 on 10/4/18 at 10:00am confirmed that the laboratory staff were discarding all unacceptable quality control results for the CBC instrument. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the hematology complete blood count (CBC) proficiency testing (PT) records and interview with Testing person #3 determined the laboratory failed to retain all PT records for at least two years in 2017 and 2018. The findings include: 1. Review of the hematology CBC PT records for 2017 and 2018 revealed the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- failed to retain the attestation sheets for 2017 events two and three and 2018 event one and two. 2. Interview with Testing Person #3 on 10/4/18 at 10:30am confirmed that the laboratory failed to retain all CBC PT records for 2017 and 2018. 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 it was determined that the laboratory did not laboratory failed to verify the performance specifications of reportable range and reference(normal) range on the CBC instrument (See D5421), failed to perform a successful calibration verification every six months when the lab's quality control did not meet the lab's criteria for acceptability (See D5439), failed to follow quality control instructions by not performing three levels of controls each day of testing (See D5441), laboratory used expired calibrators to perform calibration verification on their CBC instrument twice in 2018(See D5417), and the laboratory failed to document the refrigerator temperature on the temperature log in June 2018 (See D5413). 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 the refrigerator temperature log, chart review and interview with Testing Person #3, it was determined that the laboratory failed to document the refrigerator temperature on the temperature log in June 2018. The findings include: 1. A review of the refrigerator temperature log indicated blank boxes for the dates of 6.16.18 and 6.23.18. 2. Review of 5 patient charts indicated that Patient #5 had a CBC reported on 6.16.18 without refrigerator temperatures being documented. 3. An interview with Testing person #3 verified that CBC results are reported on Saturdays and temper are required to be documented. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other -- 2 of 7 -- supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on the observation of CBC calibrators, review of calibration records and interview with Laboratory Director, determined the laboratory used expired calibrators to perform calibration verification on their CBC instrument twice in 2018. The findings include: 1. An observation of the CBC calibrators in the laboratory refrigerator on 10/4/18 at 9:00am verified a May 2018 expiration date. 2. Review of the calibration records for 2018(May 5, 2018 & Oct. 4, 2018) verified that both calibration verification reports had flagged some parameters as needing calibration. 3. An interview with the Laboratory Director on 10/4/18 at 2:00pm verified that both calibration verification records had flagged parameters. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of the laboratory's verification studies on the complete blood count (CBC) instrument and interview with Office Manager, determined the laboratory failed to verify the performance specifications of reportable range and reference (normal) range before using the instrument to report patient results. The findings include: 1. A review of the laboratory's verification study verified that the reportable range and reference(normal) range data was missing. 2. An interview with Office Manager on 10/4/18 at 2:30pm verified that the staff were unable to locate the documents that verified the CBC instrument reportable range and normal range. 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 -- 3 of 7 -- 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 review of calibration records for the complete blood count (CBC) instrument, review of manufacturer's Operator's Guide, review of quality control (QC) records, chart review, and interview with the Laboratory Director, determined the laboratory failed to perform a successful calibration verification every six months when the lab's quality control did not meet the lab's criteria for acceptability in 2017 and 2018. Findings included: 1. A review of calibration records for the CBC instrument indicated that the calibration performed on Jan. 10, 2017 indicated a status of "Needed" for RBC(red blood cell). There were no records to verify that calibration verification was performed in June 2017 or January 2018. The June 5, 2018 calibration record indicated a status of "Needed" for WBC(white blood cell), RBC & HGB(hemoglobin). 2. Manufacturer's Operator's Guide indicates, "If needed appears for any of the parameters, calibration adjustments are required. Print the new calibration factors and place them in your log book." The print-out of the new calibration factors were not available. 3. A review of quality control records for Oct. 2107, Feb. 2018, June 2018, Aug. 2018 and Sept. 2018 verified that on 6.6.18 the high control level was missing and on 6.16.18 all three levels of QC were out of range. 4. Review of 5 patient charts indicated that Patient #4 had a CBC reported with the high level QC missing. Patient #5 had a CBC reported on 6.16.18 with all three levels of control unacceptable. 5. Interview with the Laboratory Director on 10/4/18 at 1:00pm verified that the calibration verification on the CBC instrument had not been performed on June 2017 and Jan. 2018 and the other verification results indicated needed. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the hematology instrument quality control data, chart review, and interview with Testing Person #3, it was determined that the laboratory failed to follow quality control instructions by not performing three levels of controls each day of testing for 2018. Findings include: 1. A review of quality control records for Oct. 2107, Feb. 2018, June 2018, Aug. 2018 and Sept. 2018 verified that on 6.6.18 the high -- 4 of 7 -- control level was missing and on 6.16.18 all three levels of QC were out of range. 2. Review of 5 patient charts indicated that Patient #4 had a CBC reported with the high level QC missing. Patient #5 had a CBC reported on 6.16.18 with all three levels of control unacceptable. 2. An interview with the lead testing person at 12 PM on December 16, 2009 confirmed the laboratory was alternating two levels of controls each day of testing and not doing three levels each day. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of 5 final test reports, review CBC instrument print-out, and interview with Testing Person #3 , determined the final MCH(mean corpuscular hemoglobin) result was entered incorrectly into the chart of Patient #4. The findings include: 1. Review of the CBC result for Patient #4 revealed a MCH of 32.8/pg. 2. the instrument print-out for the MCH of Patient 4 revealed a MCH of 23.8/pg. 2. An interview with Testing Person #3 on 10/4/18 at 11:01am verified that the MCH did not match between the two reports 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 record review and interview it was determined that the laboratory director failed to ensure that laboratory personnel have appropriate education (See D6028), ensure all personnel had documented initial competency (See D6029), and ensure duties and responsibilities of each person is specified in writing (See D6032). D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in -- 5 of 7 -- accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on a lack of education records and interview with the Office Manager, determined the Laboratory Director failed to ensure that the proof of highest level of education was available for all testing personnel in 2018. The findings include: 1. Education records, verifying highest degree of education, were not able to be located for testing person #2 and #7. 2. An interview with the Office Manager on 10/4/18 at 2: 00pm confirmed there was no proof of highest level of education for testing person #2 or #7. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on lack of initial training records, review of some initial training records for the laboratory testing personnel and interview with Office Manager determined the Laboratory Director failed to document initial training for 10 out of 11 testing personnel performing Hematology CBC testing in 2017 and 2018 when they were newly hired. The findings include: 1. Initial training records were not available for review for testing personnel # nine, ten and eleven that included documented review by the Technical Consultant for 2017 and 2018. 2. Review of the initial training records for testing personnel # 1, #2, #3, #4, #5, #6, and #7 dated 10.3.18 did not have the signature of the Technical Consultant to verify the testing person's training. 3. Interview with the Office Manager on October 4, 2018 at 2:30pm confirmed the initial training records dated 10.3.18 were not signed by the Technical Consultant. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. -- 6 of 7 -- This STANDARD is not met as evidenced by: Based on a review of job responsibilities and duties and interview with Testing Person #3, it was determined the Laboratory Director did not ensure that the duties and responsibilities of all staff were documented in 2017 and 2018. Findings include: 1. A review of the job responsibilities and duties verified that the duties for the technical consultant and clinical consultant were missing. 2. An interview with Testing Person #3 at 10:00am on 10/4/18 confirmed the duties for the technical consultant and clinical consultant were not available. 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 lack of competency records, review of some competency assessment records for the laboratory testing personnel and interview with Office Manager determined the Technical Consultant failed to document annual competency, which contained all six required components, for all three of the testing personnel performing Hematology CBC testing in 2017 and 2018 that were not newly hired. The findings include: 1. Competency records were not available for review for testing personnel # nine, ten and eleven that included the required six components (direct observation of patient testing, monitoring the recording and reporting of test results, review of intermediate results or worksheets, observation of performance of maintenance and function checks, assessment of test performance, and assessment of problem solving skills) with documented annual review by the Technical Consultant for 2017 and 2018. 2. Review of the competency records for testing person # 8 dated 1.27.17 and 10.3.18 did not include the required six components (direct observation of patient testing, monitoring the recording and reporting of test results, review of intermediate results or worksheets, observation of performance of maintenance and function checks, assessment of test performance, and assessment of problem solving skills) and the Technical Consultant did not verify the testing person's competency per her signature in 2017 or 2018. 3. Interview with the Office Manager on October 4, 2018 at 2:00pm confirmed the annual competencies could not be located on testing personnel #9, 10 & 11. She also confirmed that the annual competency for testing person #8 was not signed by the Technical Consultant and all of the annual competencies were lacking the required six components for 2017 and 2018. -- 7 of 7 --