Oxford Pediatric Group Pllc

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 Beckman Coulter DxH 500 QC (quality control) records from installation on 3/23/21 through 9/13/22 and confirmation with testing personnel (TP) #2 at 3:00 p.m., the laboratory failed to retain the quality control (QC) assay sheets for each lot used. QC assay sheets include acceptable ranges, storage requirements, lot numbers and standard deviations and should be kept for a minimum of 2 years. Findings include: 1. Review of the DxH 500 records indicated QC lot 3522139 was in use on the day of the survey. According to the QC records there were 8 lot numbers of QC used but the assay sheets were not retained with the change of a new lot number. 2. Review of the DxH 500 records from 3/23/21 until 9/13/22 revealed the following hematology QC lots had been used: a. DxH 500 QC lot # 352112211, 362112212, 372112213- low, normal, high expiration date- 5/5/21 b. DxH 500 QC lot # 352112511, 262112512, 372112513- low, normal. high expiration date- 8/5/21 c. DxH 500 QC lot # 352112611, 362112612, 372112613- low, normal, high expiration date- 9/5/21 d. DxH 500 QC lot # 352112811, 362112812, 372112813- low, normal, high expiration date-11/5/21 e. DxH 500 QC lot # 352112911, 362112912, 372112913- low, normal, high expiration date-12/5/21 f. DxH 500 QC lot # 352113011, 362113012, 372113013- low, normal, high expiration date- 1/5/22 g. DxH 500 QC lot # 352113111, 362113112, 372113113- low, normal, high expiration date- 2/5/22 h. DxH 500 QC lot # 352213311, 362213312, 372213313- low, normal, high expiration date- 4/5/22 3. Interview with TP#2 at 3:00 p.m. on 9/13/22 confirmed the lab did not retain QC assay sheets with each lot number of QC material for the Beckman Coulter DxH 500 hematology analyzer. 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 -- 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 document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of Beckman Coulter DxH 500 hematology analyzer maintenance records from installation on 3/23/21 through 9/13/22 and interview with the Testing Personnel (TP) #2 as listed on the CMS 209 at 2:00 p.m. on 9/13/22, the laboratory failed to document as performed the monthly maintenance on the DxH 500 analyzer as required by the manufacturer. Findings include: 1. Review of the DxH 500 records from 3/23/21 through 9/13/22 revealed the following monthly maintenance had not been documented as performed since installation on 3/23/21. Monthly or every 1,000 cycles: Perform Bleach Cycle Monthly: Clean the WBC Bath Filter B. TP#2 at 3:00 p. m. on 9/13/22 confirmed monthly maintenance was not documented as performed for the DxH 500 hematology analyzer. 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 review of laboratory testing personnel (TP) records available on 9/13/22, the CMS (Centers for Medicare and Medicaid Services) 209 form and interview with the technical consultant/laboratory director (TC/LD), TP#2 and office manager, the laboratory director had not ensured that all testing personnel as listed on the CMS 209 personnel form had received the appropriate documented training prior to performing CBC (complete blood count) testing on the DxH 500 hematology analyzer. Findings Include: 1. Based on review of laboratory personnel records and lack of training documentation available the day of survey, TP#7 and TP#8 had no initial training for moderate complexity CBC testing prior to performing testing on patients. TP #7 - hire date - 4/5/21 TP #8 - hire date - 10/21 2. An interview with the TC/LD and TP #2 at 4: 30 p.m. on 9/13/22 confirmed that no initial training for CBC testing had been documented for TP #7 and TP #8 prior to testing patients. THIS IS A REPEAT DEFICIENCY D6053 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 -- 2 of 3 -- semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of testing personnel records from 1/13/21 through 9/13/22, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with the office manager and TP #2, the technical consultant (TC) failed to evaluate and document the performance of TP #7 and TP #8 at least semiannually during the first year of employment. Findings include: 1. Review of the laboratory personnel records indicated that there were no 6 month evaluations available for TP#7 and TP #8. TP#7 hire date 4/5/21 - 6 month evaluation due in October 2021. TP#8 hire date 10/21- 6 month evaluation due in April 2022. 2. Interview with the office manager and TP #2 confirmed in an interview at 4:30 p.m. on 9/13/22 that no 6 month evaluation/competency was performed on TP #7 or TP#8 during the first year of performing moderate complexity testing. 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 review of laboratory testing personnel (TP) records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interview with the clinic office manager and TP#2, the technical consultant failed to evaluate annually and document the performance of testing personnel #2 through #7 who are responsible for performing moderate CBC (complete blood count) testing. Findings include: 1. Based on laboratory personnel records available for review on the day of survey, there were no annual evaluations/competencies performed by the technical consultant on TP #2 through TP #7 since the last survey on 1/13/21. 2. Interview with the office manager and TP #2 confirmed no annual evaluation/competencies for TP #2 through TP #7 had been performed by the technical consultant for the years 2021 and 2022. THIS IS A REPEAT DEFICIENCY -- 3 of 3 --

Summary Statement of Deficiencies 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 deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of Beckman Coulter AcT Diff Coulter ES Cell QC (quality control) records from 1/2/19 through 1/13/21, control assay sheets and interviews with testing personnel (TP) #1, #3 and #6 at 12:00 pm on day of survey (1/13/21), the laboratory failed to follow the manufacturer's instructions for the expiration date on the hematology QC material from 11/23/2020 through 1/13/21. Findings include: 1. The Beckman Coulter AcT Diff control 4C ES Cell manufacturer's instructions state vials of hematology controls (low, normal, high) may not be used past the printed expiration date on the vial. 2. Beckman Coulter 4C ES Cell Controls which were observed in the refrigerator on the day of survey had a printed expiration date of 11/23 /2020 and were still in use on 1/13/2021. The controls in use were: Low Control lot number 06830- expiration date 11/23/2020 Normal lot number 07830 - expiration date 11/23/2020 High lot number 08830 - expiration date 11/23/2020 3. Lot numbers 06830, 07830 and 08830 (Beckman Coulter 4C ES Cell Controls) were in use on the day of survey 1/13/21. 4. Interview with TP #1, #3 and #6 confirmed the controls mentioned above were in use the day of survey and had been used since the expiration date of 11/23/2020. CBC's (Complete Blood Counts) had been performed and reported on approximately 248 patients during the time period from 11/23/2020 through 1/13/2021. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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 -- 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 the lack of education and training documentation available the day of survey (1/13/21) and interview with TP #1 and office manager, the laboratory director had not ensured that testing personnel (TP) listed on the CMS (Centers for Medicare and Medicaid Services) 209 personnel form as TP # 7 and #8 had the appropriate education and training to perform moderate complexity testing prior to testing patients. Findings Include: 1. There was no documented education or training available to review for TP #7 or #8 on the day of survey. 2. TP #7 and #8 began testing samples in October 2020 based on review of QC (Quality Control) and PT (Proficiency Testing) records. 3. Interview with the office manager prior to the survey on 1/13/21 and with TP #1 on 1/14/21 via telephone, confirmed initial training for the TP #7 and #8 was not documented as performed before they began performing moderate complexity laboratory testing. 4. There was no documentation available to indicate that the laboratory director had ensured testing personnel had the proper education or training before allowing TP #7 and #8 to begin performing moderate complexity laboratory testing on patient samples. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of moderate complexity laboratory testing records from 7/2/18 through 1/13/21 and interview with the technical consultant at 1:00 pm on 1/13/21, the Technical Consultant had not documented review of laboratory records such as Quality Control (QC), Proficiency Testing (PT), worksheets. Findings Include: 1. Review of the laboratory records from 7/2/18 through 1/13/21 revealed the following records had not been documented as reviewed by the technical consultant since 6/7 /18: a. AcT Diff hematology quality control (QC) records from 1/2/19 through 1/13 /21. b. AcT Diff hematology calibration records from 4/7/19 through 12/14/2020. c. Temperature records (room, refrigerator, freezer) from 7/2/18 through 1/13/21 d. Proficiency records (3rd event of 2018, 2nd and 3rd events of 2019 and all 3 events of 2020) 2. Interview with the technical consultant at 1:00 pm on the day of the survey (1 /13/21) confirmed he had not documented review of the records.. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the -- 2 of 3 -- 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 lack of documentation of annual evaluations/competency records on the day of survey, 1/13/21, review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and interview with TP and clinic office manager, the Technical Consultant failed to evaluate annually and document the performance of TP responsible for performing moderate complexity laboratory testing. An annual evaluation/competency must be performed each year of employment by the technical consultant. Findings include: 1. There were no Competency/Evaluation records available for review for TP #1, #2, #3, #4, #5, and #6 on 1/13/21. 2. Interview with the TP #1 and clinic manager confirmed the annual evaluation/competencies for TP #1 through #6 had not been documented as performed by the technical consultant since the last survey on 6/7/2018. -- 3 of 3 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of Beckman Coulter AcT Diff Coulter ES Cell QC (quality control), control assay sheets and confirmation with testing personnel #1 at 12:00 pm, the laboratory failed to follow the manufacturer's instructions for the opened vial stability for the hematology QC material from 3/28/18 through 5/9/18. Findings include: The Beckman Coulter AcT Diff control 4C ES Cell manufacturer's instructions state the hematology controls (low normal, high) should only be used for 35 days or a maximum of 20 entries after opened. The following AcT Diff hematology controls were in use past the open vial stability expiration date: Beckman Coulter 4C ES Cell Control - Opened and used on 3/28/8 through 5/9/18: Low Control lot number 069300 exp date 6/18/18 Normal lot number 079300 exp date 6/18/18 High lot number 089300 exp date 6/18/18 According to staff the control vials were used until empty which exceeded the opened vial expiration dates required by the manufacturer. Approximately 150 patient samples were run during this time period from 3/28/18 through 5/9/18. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --