Pediatric Associates Of Mont Co

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 the "Parallel QC [quality control] Procedure", parallel testing log book for the Medonic M-series (hematology analyzer) and interview with the office manager (OM), the laboratory failed to perform parallel testing of the QC materials with each new lot as required by the manufacturer. Findings: 1. The "Parallel QC Procedure" states that the old QC lot and the new QC lot are to be tested on the same day and comparied prior to switching to the new lot of QC materials. 2. The records in the parallel testing log book from September 2023 through October 2024 were reviewed. 3. The records from 12/4/2023 included documentation that stated the testing person had forgotten to compare the previous QC materials with the new controls. A note placed on the new "For Medonic M-series with barcode reader" worksheet stated that the comparison was done using the old QC results from the previous day and not the day that the new QC was started. The only records attached to the worksheet were the results of the new lot of QC materials. 4. The records from 4 /15/2024 included documentation stating that the testing person had forgotten to test the old and new QC materials on the same day. There were no QC records attached to the "For Medonic M-series with barcode reader" worksheet. 5. During the survey on 11/13/2024 at 11:45 AM, the OM confirmed that the parallel testing on the hematology analyzer had not been performed as required by the manufacturer. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(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. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the office manager (OM), the laboratory director failed to specify in writing, the responsibilities and duties of each person engaged in the performance of the pre-analytic, analytic and post analytic phases of testing, that identifies which examination and procedure each individual is authorized to perform, and whether supervisory or director review is required prior to reporting patient test results. Findings: 1. The procedure manual included the duties and responsibilities of the laboratory director, technical consultant, medical laboratory technician (qualified with a 2 year degree), and nursing- lab responsibilities (which only included waived testing). The procedure did not include duties and responsibilities for testing personnel and/or medical assistance that qualified with only a high school diploma and medical assistant certificate. 2. According to the OM, QC and QA records are sent to the technical consultant (TC) on a monthly basis. The duties and responsibilities of the laboratory director and TC fail to include written instructions for what records are to be reviewed, when these records are to be emailed for review, and the turnaround time for the evaluation of these records. 3. During the survey on 11/13/2024 at 11:45 AM, the OM confirmed that the laboratory's procedure manual did not specify in writing the duties and responsibilities of the qualified laboratory testing personnel and the timely evaluation of QC and QA records. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on review of the monthly quality assessment (QA) review worksheets and interview with the office manager (OM), the technical consultant (TC) failed to ensure that monthly QA records were reviewed in a timely manner to ensure that problems were identified and

Summary Statement of Deficiencies 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 record review and interview, the laboratory did not rotate proficiency testing among testing personnel. Findings: 1. Testing person A tested and reported hematology results for all three proficiency test events in 2022 and two proficiency test events in 2023. The testing was not rotated among other testing personnel. 2. The technical consultant confirmed that the proficiency testing was not rotated among all testing staff during interview on the afternoon of the of the survey. 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 competency check records and interview, the technical consultant did not have records showing evaluation of competency of testing personnel in 2022. Findings: 1. The technical consultant did not have competency evaluations in 2022 for testing person A, testing person B and testing person C. These records were not 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 -- available for review during the survey. 2. The technical consultant confirmed that competency check records for the three testing persons were not available, during interview on the afternoon of the day of survey, -- 2 of 2 --

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: Based on review of the federal report for unsuccessful proficiency testing (PT) results and review of the comparative evaluation report from American Proficiency Institute (API), the laboratory failed to successfully participate in the API PT program for hematology testing, in which the laboratory is certified under CLIA (D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the federal report for unsuccessful proficiency testing (PT) results and review of the comparative evaluation report from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for the same analyte in two consecutive testing events. Findings: 1. The laboratory received the following scores from API for white blood cell differential testing: a. 53% in the 2022 2nd PT event b. 67% in the 2022 3rd PT event 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 review of the federal report for unsuccessful proficiency testing (PT) results and review of the comparative evaluation report from American Proficiency Institute (API), the laboratory director failed to ensure an approved

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Note: This is a repeat deficiency. The laboratory was cited during the recertification survey completed on 01/23/2019 for not having a procedure for verifying performance of new hematology quality control (QC) lot numbers by testing them in parallel with current QC lot numbers as well as not having documentation that new QC lot numbers were tested in parallel with current QC lot numbers for performance verification. The laboratory's

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: A. Based on review of competency assessment records for laboratory (lab) staff and interview with the technical consultant, the lab director did not perform competency assessments for the technical consultant. Findings: 1. The competency assessments records for 2017 and 2018 did not include competency checks for the technical consultant; and 2. The technical consultant, during interview on the day of survey stated that the director did not perform competency checks for the duties she performs as technical consultant. B. Based on review of competency assessment records for laboratory (lab) staff and interview with the technical consultant, the lab did not ensure that all elements of the competency assessment for staff performing throat culture testing (reading selective strep agar plates) were performed. Findings: 1. Records show that only the proficiency testing was evaluated as the competency check for medical staff interpreting throat culture plates for presence or absence of Group A beta strep; 2. Lab staff were not evaluated by methods of observation, record review and problem solving as part of the competency check; and 3. The technical consultant, during interview in the morning of the day of survey stated that the staff performing the throat culture testing were only evaluated by proficiency testing. 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 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 -- 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 record review and interview, the hematology lab did not have written quality control procedures to ensure accurate and reliable testing. Findings: 1. The technical consultant stated during interview on the day of the survey that the hematology quality control result(s) can be accepted if result(s) for two of the three quality control reagents fall within the manufacturers published range and that the lab did not take into account whether or not the third failed quality control result(s) exceeded three standard deviations from the mean of the published value or was unacceptable on consecutive days of testing; 2. The laboratory did not have written procedures instructing staff to not accept quality control results that are greater than 3 standard deviations (as given by the manufacturer) from the mean even though the other two quality control reagents fall within the manufacturers stated range; 3. The lab did not have written procedures instructing staff to not accept quality control results when a control result exceeds the manufacturers stated range on consecutive days of testing; 4. The laboratory accepted quality control results when one of the three hematology control results did not meet the manufacture's allowable range and that result was also greater than 3 standard deviations away from the mean value as given by the manufacturer; 5. On July 21, 2017 the normal result for the white blood cell count control was 7.0 [x10(3) microliters], the lab accepted this result even though it was greater than 4 standard deviations from the allowable mean, using the manufacturers statistics (the control reagent manufacturer limits for the normal WBC count are 8.2 to 9.6); 6. On July 5, 2017 the normal result for the white blood cell count control was 7.9 [x10(3) microliters], the lab accepted this result even though it was greater than 3 standard deviations from the allowable mean, using the manufacturers statistics (the control reagent manufacturer limits for the normal WBC count are 8.2 to 9.6); 7. On February 13, 2017 the normal result for the platelet count control was 284 and 269 [x10(6) microliters], the lab accepted the results (control was tested in duplicate) even though both values were greater than 3 standard deviations from the allowable mean, using the manufacturers statistics (the control reagent manufacturer limits for the normal RBC count are 168 to 248); 8. On January 30, 2017 the normal result for the platelet count control was 269 [x10(6) microliters], the lab accepted the result (control was tested in duplicate) even though it was greater than 3 standard deviations from the allowable mean, using the manufacturers statistics (the control reagent manufacturer limits for the normal RBC count are 168 to 248); and 9. The result of the high level quality control reagent for white blood cell count failed to meet the manufacturers stated range on 4/14/17 when the control also failed on the previous day of testing (4/7 /17). 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-- -- 2 of 3 -- (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: A. Based on record review, the lab did not perform quality control procedures and check strep select agar plates upon receipt. Findings: 1. The laboratory written quality control policy for selective strep agar (SSA) states that the agar plates will be documented upon receipt and the media characteristics will be documented to ensure media is not substandard quality; and 2. SSA plates with the lot numbers 1709502 (expiration date: 7/12/17) and 1703905 (expiration date: 5/17/17) were not reported in the receipt records and did not have their characteristics evaluated upon receipt. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the lab did not verify that hematology quality control reagents provide results that agree with the manufacturers stated statistical performance (parallel quality control checks). Findings: 1. The lab did not have written procedures for verifying the performance of hematology quality control reagents prior to use and in parallel with the current reagents to be replaced; 2. The lab did not have quality control records showing that parallel quality control checks were performed prior to use of new control reagents; and 3. These findings were confirmed with the technical consultant during interview on the day of survey. -- 3 of 3 --