Pediatric & Adolescent Medicine Of East Memphis Pc

Summary Statement of Deficiencies 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 laboratory observation, a review of the laboratory's procedure manual, a review of testing personnel competency assessment records, and staff interview, the laboratory failed to follow the established testing personnel competency assessment policy when the six required elements were not included in the competency assessments for three of three testing personnel, four of four competency assessments reviewed from 2024 for performance of patient testing for the Complete Blood Count with White Blood Cell Differential (CBC w/Diff) using the Beckman Coulter DxH 500 instrument. The findings include: 1. Laboratory observation on 01/22/25 at 11:45 a.m. revealed the Beckman Coulter DxH 500 (Serial number DB04006) used for patient testing for CBC w/Diff. 2. A review of the laboratory's Quality Assurance Plan under section "VI. Personnel Assessment" revealed that testing personnel evaluations would be performed using direct observation of routine testing, monitoring the recording and reporting of results, review of worksheets, quality control records, proficiency testing records, and preventative maintenance records, direct observation of instrument maintenance and function checks, assessment of test performance through testing of previously analyzed specimens or external proficiency samples and assessment of problem-solving skills. 3. A review of testing personnel competency assessment records revealed the following: Testing person one: The six-month competency assessment performed on 02/09/24 did not include documentation of test performance assessment through previously analyzed samples or external proficiency testing. The annual competency assessment performed on 07/11/24 did not include 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 -- direct observation of routine testing, monitoring the recording and reporting of results, review of worksheets, quality control records, proficiency testing records, and preventative maintenance records, direct observation of instrument maintenance and function checks, or assessment of test performance through testing of previously analyzed specimens or external proficiency samples. Testing person two: The annual competency assessment performed on 08/08/24 did not include direct observation of routine testing, monitoring the recording and reporting of results, review of worksheets, quality control records, proficiency testing records, and preventative maintenance records, direct observation of instrument maintenance and function checks, or assessment of test performance through testing of previously analyzed specimens or external proficiency samples. Testing person three: The annual competency assessment performed on 08/08/24 did not include direct observation of routine testing, monitoring the recording and reporting of results, review of worksheets, quality control records, proficiency testing records, and preventative maintenance records, direct observation of instrument maintenance and function checks, or assessment of test performance through testing of previously analyzed specimens or external proficiency samples. 4. The laboratory director confirmed the survey findings during an interview on 01/22/25 at 2:30 p.m. -- 2 of 2 --

Summary Statement of Deficiencies 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, personnel records, and staff interview, the laboratory failed to follow it's own policy for technical consultant competency assessment in 2022 and 2023. The findings include: 1. Review of the laboratory policy titled "QUALITY ASSURANCE PLAN" section VI. "Personnel Assessment" revealed "Competency of technical consultant will be reviewed on an annual basis" and further stated "If a new technical consultant is hired, competency will be reviewed quarterly the first year, then annually thereafter". 2. Technical consultant competencies were not available on the date of the survey (11/21/2023). 3. Interview on 11/21/2023 at 12:15 pm with the technical consultant confirmed the laboratory failed to follow the Personnel Assessment policy for technical consultant competency assessments in 2022 and 2023. 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 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 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer instructions for use, environmental records, and staff interview, the laboratory failed to monitor humidity environmental conditions where the DxH 500 complete blood count (CBC) instrument was in use for patient testing in 2022 and 2023. The findings include: 1. Observation of the laboratory on 11/21/2023 at 9:30 am revealed a Beckman Coulter DxH 500 (Serial BD040006) instrument in use for patient CBC testing. 2. Review of the manufacturer instructions for use revealed an environmental operating humidity requirement maximum of 80%. 3. Review of the laboratory environmental monitoring logs revealed humidity was not recorded for the area where the DxH 500 CBC instrument was in use for patient testing in 2022 and 2023. 4. Interview on 11/21/2023 at 9:35 am with the laboratory director confirmed the laboratory did not monitor room humidity conditions where the DxH 500 CBC analyzer was in use in 2022 or 2023. -- 2 of 2 --

Summary Statement of Deficiencies 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 integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory records and staff interview, testing personnel failed to sign the attestation statement for one of four available attestation statements. The findings include: 1. Review of the laboratory's proficiency testing records revealed that 2021 event two attestation statement was not signed by the person who performed the testing. 2. Interview with the laboratory director on 02/02/2022 at approximately 4 pm confirmed the survey findings. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on review of laboratory records and staff interview, the laboratory failed to retain attestation statements for one of five proficiency testing (PT) events. The findings include: 1. Review of proficiency testing records revealed no retention of the attestation statement for 2021 event one. 2. Interview with the laboratory director on 02/02/2022 at approximately 4 pm confirmed the survey findings. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, patient test reports and staff interview, the laboratory procedure for complete blood count (CBC) was not approved by the laboratory director before patient testing in 2020. The findings include: 1. Review of the laboratory procedure titled "COMPLETE BLOOD COUNT BY BECKMAN COULTER DxH 500 ANALYZER" revealed approval by the lab director on 12/11/2020. 2. Review of the first patient reported on the Beckman Coulter DxH complete blood count instrument revealed patient testing began on 11/13 /2020 (patient 1022). 3. Interview with the laboratory director on 02/02/2022 at approximately 4 pm confirmed the procedure for CBC performed on the DxH instrument was not approved before use. 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 observation of the laboratory, review of laboratory records, and staff -- 2 of 5 -- interview, the laboratory failed to follow the manufacturer's instructions for calibration verification of the Beckman Coulter DxH complete blood count instrument (one of three calibrations reviewed). The findings include: 1. Observation of the laboratory on 02/02/2022 at approximately 11:15 am revealed the Beckman Coulter DxH 500 on the counter in use for patient CBC testing (serial number DB040006). 2. Review of laboratory records revealed the following: Calibration of the instrument was performed on 10/28/2021. The manufacturer instructions for use stated to "Verify calibration using DxH 500 Series Calibrator as indicated in the calibrator's Instructions for Use." The calibrator package insert states the following "Verify calibration by analyzing a new tube of calibrator and repeat section A & B." There was no evidence that the calibration was verified after calibration was performed. Patient test records showed four patients were reported after the calibration, before any verification of the calibration was performed (patient numbers 3674, 5694, 7353, and 9724). 3. Interview with the laboratory director on 02/02/2022 at approximately 4 pm confirmed the survey findings. 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: The laboratory director failed to have the appropriate laboratory training or experience for performing technical consultant duties (Refer to D6034), the technical consultant failed to approve test method validations (Refer to D6040), the technical consultant failed to review quality control (Refer to D6042) and the technical consultant failed to perform training and competency assessments as indicated in the laboratory policy (Refer to 6046). D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (Form CMS-209), laboratory records and staff interview, the laboratory director failed to have the laboratory training or experience for performing technical consultant duties in 2020 and 2021. The findings include: 1. Review of the Form CMS-209 revealed no technical consultant was listed. 2. Review of laboratory records revealed the following: The laboratory director had performed technical consultant duties include review of quality control, review of proficiency testing results and training and competency assessment of testing personnel. The laboratory records and personnel records did not include any evidence that the laboratory director -- 3 of 5 -- had the required laboratory training or experience for performing technical consultant duties. 3. Interview with the laboratory director on 02/02/2022 at approximately 4 pm confirmed the lab director performed technical consultant duties in 2020 and 2021 without the required laboratory training or experience. The laboratory director stated she realized that she had not retained a technical consultant (after the previous one retired) when she was filling out the paperwork. The time frame since the last technical consultant was retained/available was unclear. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory records, and staff interview, the technical consultant failed to review and approve validations performed on the Beckman Coulter DxH 500 complete blood count (CBC) instrument in 2020. The findings include: 1. Observation of the laboratory on 02/02/2022 at approximately 11:15 am revealed the Beckman Coulter DxH CBC instrument on the counter in use for patient testing. 2. Review of laboratory records revealed validations for DxH 500 CBC instrument were completed and printed on 10/30/2020. There was no evidence the validations had been reviewed or approved. Patient test records indicated the first patient was tested on 11/13/2020 (patient 1022). 3. Interview with the laboratory director on 02/02/2022 at approximately 4 pm confirmed a technical consultant had not reviewed or approved the validations performed for the Beckman Coulter DxH CBC instrument in 2020. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, quality control records, and staff interview, the technical consultant failed to review complete blood count (CBC) quality control for four out of twelve months in 2021. The findings include: 1. Review of the laboratory's quality assurance policy revealed that "The quality control program for calibration and control data for each test method used in the lab will be reviewed by the laboratory director and technical consultant (via fax) monthly." 2. Review of the laboratory's quality control records revealed no review of the following quality control lots as follows: 352112311, 362112312, 372112313 in use from 04/27/2021 to 05/24/2021 352112411, 362112412, 372112413 in use from 05/25/2021 to 06/21 /2021 352112511, 362112512, 372112513 in use from 06/23/2021 to 07/29/2021 -- 4 of 5 -- 352112711, 362112712, 372112713 in use from 07/29/2021 to 08/25/2021 3. Interview with the laboratory director on 02/02/2022 at approximately 4 pm confirmed the survey findings. 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 review of the laboratory procedure manual, testing personnel training and competency assessment records, and interview with the laboratory director, the technical consultant failed to perform competency assessments for testing personnel in 2019, 2020, 2021 and 2022 for six of six testing personnel. The findings include: 1. Review of the laboratory procedure manual revealed that all personnel will have training for tests they perform, semiannually competency assessment the first year, and then annually thereafter. 2. Review of testing personnel training and competency assessment records revealed the following: Initial training and competency for testing personnel numbers two and three performed by the lab director who does not meet the regulatory experience requirement. No interim competency assessments for testing personnel numbers two and three. No annual competency assessments for testing personnel numbers one, four, five and six for 2019, 2020 (for the previous CBC instrument) and 2021. No annual competency assessment for testing personnel numbers two and three for 2020 and 2021. No annual competency assessments had been performed in 2022. 3. Interview with the lab director on 02/02/2022 at approximately 4 pm confirmed the survey findings. There was no performance of competency assessment as indicated in the laboratory policy in 2019, 2020, 2021, and 2022. -- 5 of 5 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the Beckman Coulter AcT Diff complete blood count (CBC) instrument operator's manual, the calibration records for the Beckman Coulter AcT Diff CBC instrument, quality control records, patient data logs and interview with the technical consultant, the laboratory failed to follow manufacturer's instructions for calibration when it did not perform quality control after calibration in 2017 and 2018 with patients reported. 1. Review of the Beckman Coulter AcT Diff operator's manual revealed the following statement under the section for calibration: "Verify calibration by analyzing one replicate for each level of control." 2. Review of the laboratory's calibration records for the Beckman coulter AcT Diff CBC instrument revealed calibration performed on 6.14.17 at 8:52 am and 6.15.18 at 1:00 pm. 3. Review of the laboratory's quality control records for 6.14.17 and 6.15.18 revealed no quality control was performed after instrument calibration. 4. Review of the patient data logs for 6.14.17 and 6.15.18 revealed the following: 8 patients reported on 6.14.17 after calibration was performed without quality control 2 patients reported on 6.15.18 after 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 -- calibration was performed without quality control 5. Interview with the technical consultant on 11.01.18 at 2:00 pm confirmed the laboratory failed to follow manufacturer instructions for calibration when it did not perform quality control after calibration in 2017 and 2018 with 10 patients reported. -- 2 of 2 --