Bee Caves Pediatrics,Pa

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. 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 manufacturer's instructions, the laboratory's policy and procedure, calibration records, pre-survey paperwork, and interview, the laboratory failed to follow the user's manual for performing calibrations for the Medonic M- Series Complete Blood Count (CBC) for one of four calibrations reviewed from July 2022 - January 2024. Findings follow. A. Review of the Medonic M-Series User's Manual, May 2009 Article # 1504248, under 7.2 Calibration stated, "Follow the instructions below to calibrate: ... Step 9 If all parameters have acceptable CVs proceed to the next step, if not rerun calibration following steps above. Step 10 The new calibration factor can be entered in three ways. The recommended method is to select the [USE CAL] button which will automatically calculated the new calibration factor using target range from assay values [hand written instructions stated, 'have to 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 -- push for all 6 parameters, will only ask for ID & code for first value'] (other 2 options marked out)... Step 11 In the first and second methods the calibration factor is automatically calculated once either the [USE CAL] button is pressed or target value is entered. Step 12 Once calibration factor has been entered using one of the methods above, operator will be prompted to enter a 4-digit Operator ID... and Authorization Code (REQUIRED) before the new value can be changed or updated. NOTE: Authorization Code prompt is displayed only once per calibration sequence when [USE CAL], [TARGET VALUE], or [NEW CAL FACTOR] buttons are pressed. Step 13 Authorized operator can update or change calibration factor by inputting the Authorization Code [2576]. Step 14 Perform steps 9-12 for RBC, MCV, PLT, HGB, WBC, and MPV parameters. To move to the next parameter press [NEXT]. Step 15 It is recommended to not change preset calibration factors for RDW%... Step 16 Once parameters are calibrated, press [EXIT] and a screen will be displayed asking operator if a calibration report is wanted, [SEND], [PRINT], or [EXIT] can be selected. It is recommended that calibration reports be printed and archived in case it may be needed for future reference [with the handwritten instructions 'must completely exit out of calibration menu before this will pop up'] (Pop up stated, 'Do you want a calibration report? Print')". The laboratory failed to perform steps 13-16. B. Review of the laboratory's policy and procedure titled CBC Medonic M-Series, approved 01/12 /2021, at Calibration stated, "Calibration of the Medonic M-Series should occur at least once every 6 months or any time quality control values indicate that the instrument is 'out' of calibration or following major maintenance procedures or parts replacement. Whole blood calibration material is available commercially and ready to use. Refer to manufacturer's package insert for specific instructions on storage and mixing and Section 7.2 of the User's manual for operational instructions." C. A Review of the calibration records from July 2022 - January 2024, as listed by date performed, revealed: 1. 07/22/2022: The post calibration report showed RBC, MCV, PLT, MPV, HGB, and WBC were successfully calibrated on 07/22/2022. 2. 01/24 /2023: The pre-calibration report showed the last calibration was on 07/22/2022. The post calibration report showed only RBC was calibrated on 01/24/2023. MCV, PLT, MPV, HGB, and WBC still showed the last calibration was on 07/22/2022 (elapsed time of 6 months). 3. 07/26/2023: The pre-calibration report showed RBC was calibrated on 01/24/2023. MCV, PLT, MPV, HGB, and WBC showed the last calibration was on 07/22/2022. The post-calibration report showed RBC, MCV, PLT, MPV, HGB, and WBC were successfully calibrated on 07/26/2023 (elapsed time of 12 months for MCV, PLT, MPV, HGB, and WBC). 4. 01/31/2024 The post calibration report showed RBC, MCV, PLT, MPV, HGB, and WBC were successfully calibrated on 01/31/2024. D. Review of the CMS-116 showed a CBC annual test volume of 1770. E. Interview with the Technical Consultant (as listed on the CMS- 209) on April 2, 2024 at 1400 hours in the patient room verified the findings after a review of the records. KEY: RBC = Red Blood Cell Count MCV = Mean Corpuscular Volume PLT = Platelet MPV = Mean Platelet Volume HGB = Hemoglobin WBC = White blood cell count RDW = Red cell Distribution Width D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of patient test reports, pre-survey paperwork, and interview, the laboratory failed to provide the reference ranges for the Throat Culture Screen for Group A Streptococcus for five of five test reports for in-house throat cultures reviewed from March 2023 - March 2024. Findings follow. A. Review of 5 in-house throat culture test reports from 03/13/2023 - 03/12/2024 showed no reference ranges on the patient test report, as listed by accession number and collection date: 1. #1608033, 03/13/2023 2. #1726026, 08/02/2023 3. #1838131, 12/06/2023 4. #1889369, 02/05/2024 5. #1921422, 03/12/2024 B. Review of the CMS-116 showed a throat culture annual test volume of 701. C. Interview with Technical Consultant (as listed on the CMS-209) on April 2, 2024 at 1635 hours in the patient room acknowledged they should be able to fix that. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, testing logs, and interview, the laboratory failed to read the Group A Strep Throat Culture plates at 18-24 hours and again at 48 hours for 7 out of 84 throat cultures tested from 01/06/2022 - 02/15 /2022. A. Review of the laboratory's policy and procedure titled Throat Culture Screen, approved 01/11/2016, stated under Specimen Required, "NOTE: Throat culture reading should occur after 18-24 hours of plate incubation. Final (2nd) readings must be performed prior to 48 hours of plate incubation. Samples must be referred to a reference laboratory if these time limits for plate readings cannot be met." B. Review of patient testing logs from 01/06/2022 - 02/15/2022 showed 7 specimens were not read at the specified times: a. On 1/06/2022 at 1531 a specimen was set up for throat culture. The first reading was on 1/07/2022 at 0730 and the second reading was on 01/10/2022 at 0800 (elapsed time was 88 hours, 29 minutes). b. On 01/06/2022 at 1549 a specimen was set up for throat culture. The first reading was on 01/07/2022 at 0730 and the second reading was on 01/10/2022 at 0800 (elapsed time was 88 hours, 11 minutes). c. On 01/07/2022 at 1315 a specimen was set up for throat culture. The first and second readings were on 01/10/2022 at 0800 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 -- (elapsed time was 66 hours, 45 minutes). d. On 01/07/2022 at 1428 a specimen was set up for throat culture. The first and second readings were on 01/10/2022 at 0800 (elapsed time was 65 hours, 32 minutes). e. On 01/07/2022 at 1428 (different patient) a specimen was set up for throat culture. The first and second readings were on 01/10 /2022 at 0800 (elapsed time was 65 hours, 32 minutes). f. On 01/20/2022 at 0830 a specimen was set up for throat culture. The first reading was on 01/21/2022 at 0745 and the second reading was on 01/24/2022 at 0736 (elapsed time was 95 hours, 6 minutes). g. On 01/20/2022 at 1356 a specimen was set up for throat culture. The first reading was on 01/21/2022 at 0734 and the second reading was on 01/24/2022 at 0736 (elapsed time was 89 hours, 40 minutes). All above patient results were reported as negative. C. Interview with testing personnel #2 listed on the CMS form 209 on March 16, 2022 at 1245 in the patient room acknowledged [testing personnel #5] was covering for [testing personnel #1] and didn't tell anyone she wasn't coming in to read [the plates on Saturday]. -- 2 of 2 --

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 review of proficiency testing (PT) records and interview, the laboratory failed to sign the attestation statement attesting that proficiency testing samples were handled in the same manner as patient testing for 3 of 6 Microbiology events and 2 of 6 Hematology events. Findings follow. A. Review of the American Proficiency Institute (API) proficiency testing records from the 1st, 2nd and 3rd events of 2019 and 2020 showed the three Microbiology events in 2020 were lacking signed testing personnel attestation statements for Throat Cultures reporting Positive or Negative for Group A Strep. Review of the Attestation Statement page stated, "The undersigned certify that, as closely as possible, these proficiency testing samples were tested in the same manner as patient specimens." 1. Review of the 1st event of 2020 showed no signatures for specimens TH-03, TH-04, and TH-05. A note was documented by the Technical Consultant (TC) to "see Daily Log" and "the employee [was] no longer here." 2. Review of the 2nd event of 2020 showed no signature for specimens TH-06, TH-07, TH-08, TH-09, and TH-10. A note was documented by the TC to "see Daily Log (again)." 3. Review of the 3rd event of 2020 showed no signatures for specimens 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 -- TH-011, Th-12, Th-13, Th-14, and TH-15. A note was documented by the TC "testing personnel no longer at clinic." B. Review of the API proficiency testing records from the 1st, 2nd and 3rd events of 2019 and 2020 showed the 1st and 2nd events in Hematology 2020 were lacking signed testing personnel attestation statements for Hematocrit, Hemoglobin, Lymphocytes, Mid, Granulocytes, Mean Corpuscular Hemoglobin, Mean Corpuscular Hemoglobin Concentration, Mean Corpuscular Volume, Platelet Count, Red Cell Count, White Cell Count. Review of the Attestation Statement page stated, "The undersigned certify that, as closely as possible, these proficiency testing samples were tested in the same manner as patient specimens." 1. Review of the 1st event of 2020 showed no signatures for specimens HSY-03, HSY- 04, HSY-05. A note was documented by the Technical Consultant (TC) that the employee was "no longer here." 2. Review of the 2nd event of 2020 showed no signature for specimens HSY-06, HSY-07, HSY-08, HSY-09, and HSY-10. A note was documented by the TC to "see individual print-outs...daily log initials." C. Interview with the TC on the CMS form 209 on January 12, 2021 in the patient room acknowledged testing personnel were no longer here and the problems were not identified until her review and the problem had been discussed with the clinic manager. 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: I. Based on review of the manufacturer's package insert, laboratory's procedure, reagent logs, interview, and patient testing records, the laboratory failed to follow the test procedure for Throat Cultures when they obtained and used the wrong plates to identify positive or negative for Group A Strep. Findings follow. A. Review of the Strep Select Agar package insert under III. Principles of the Procedure stated, "growth support characteristics of Strep Select Agar are derived from the presence of peptones prepared from pancreatic digest of casein and soybean meal. Sheep blood provides both X factor (hemin) and a visualization of hemolytic reactions. Colistin and nalidixic acid, antimicrobial agents, create a selective environment for gram positive organisms by either disrupting the cell membrane or blocking DNA replication of susceptible gram-negative organisms." and under II. Summary and Explanation stated, "This medium was described by Roantree et al for the isolation of Group A streptococci. Differentiation may be accomplished by characteristics such as Beta hemolysis, inhibition by 0.04 unit bacitracin discs and/or serological tests. Sheep blood is incorporated for determination of hemolytic activity." B. Review of the laboratory's procedure titled Throat Culture Screen, approved on 1/11/2016, stated, "Presumptive identification of Group A Streptococcus is easily made by demonstrating the inhibition of growth of the organism around a 0.04 unit bacitracin disk. The method of choice is to test pure culture isolates or to utilize a Strep selective media." Under Materials Required listed, "Group A Selective Strep Agar with 5% Sheep Blood". C. Review of the laboratory's documentation of agar plates received in the laboratory contained Hardy Diagnostic Blood Agar Plates, Lots 438742 and 442373, and indicated 3 and 4 packages (of 10 plates per package) were received, respectively. Documentation of the error on the back side of the page stated, "6/12/19 -- 2 of 4 -- - 9/03/19 was using Blood Agar plates. 9/03/19 noticed wrong plates and order Strep Select Agar will switch once received new plates - RY." D. Interview with the Technical Consultant on the CMS form 209 on January 12, 2021 at 1110 in the patient room confirmed Blood Agar plates were used instead of Strep Selective plates. E. Review of patient testing logs for Throat Cultures from 6/12/2019 - 9/03/2019 showed 85 patients were tested. The laboratory routinely tested 2 patients per plate. Below is a partial list of patients tested as listed by dates of testing with the number of patients tested (see testing log): 1. 06/14/2020: 3; 2. 06/17/2020: 6; 3. 06/18/2020: 2; 4. 06/19 /2020: 1; 5. 06/20/2020: 1. II. Based on review of the manufacturer's instructions, the laboratory's policy and procedure, patient test reports, and interview, the laboratory failed to redact test results on the Complete Blood Count (CBC) using the Medonic M- series Hematology analyzer when flags were obtained on 3 out of 6 CBC patient test reports. A. Review of the Medonic M-series User Manual under 9.2 System Information Messages starting on page 70 stated, "The system software monitors a number of analytical and system functions and will display information that indicates the possible attention of the operator. This information will alert the operator to check the system or sample or institute selected troubleshooting procedures. This information is presented on the touch screen as a code next to one or more parameters." The various flags listed indicated the sample must be "re-analyzed" or was "too old or pathological sample". B. Review of the laboratory's CBC Medonic M- Series procedure, version 6/12, stated under Patient Testing "5. Report results according to standard laboratory policy. NOTE: ... See the User's Manual (pages 69- 74) for out of range and message descriptions." With a hand-written addendum which stated, "TM, BD, NM, OM Flags may indicate possible sample/result problem and should not be reported. Recollect or send to reference lab. Cross result out on report and do not report in EMR." C. Review of 3 of 6 CBC test reports showed all the reports with flags were reported as identified below by patient initials and insturment sequence number: 1. 12/02/2020: # 3887; 2. 10/08/2020: #3664; 3. 10/07/2020: #3658. D. Interview with the Technical Consultant on the CMS form 209 on January 12, 2021 at 1300 in the patient room confirmed indicies with flags were reported. KEY: EMR - Electronic Medical Record 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 manufacturer's instructions, maintenance records and interview, the laboratory failed to document maintenance on the Medonic Hematology analyzer for Complete Blood Counts (CBCs) for 4 of 12 months reviewed. Findings follow. A. Review of the Medonic M-series User's Manual Section 8: Cleaning, Maintenance & Transport section of the manual on page 64 under 8.2 Monthly Cleaning stated, "This section describes the cleaning procedure to be used to secure the correct function of the instrument on a monthly basis" and described the Cleaning Procedure and Clot Prevention. Under Clot Prevention also stated, "this process will decrease the risk of debris material building up in the instrument system. This should be performed at least once a month or every 1000 samples." B. Review of the Maintenance Log for Medonic M-Series showed no documentation of the monthly maintenance: Clean Procedure and Clot Prevention for the months of January, April, May, and July of -- 3 of 4 -- 2020. C. Interview with the Technical Consultant on the CMS form 209 on January 12, 2021 in the patient room acknowledged she will review with testing personnel #1 on the CMS form 209 and make sure she is on track. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the patient test reports and interview, the laboratory failed to ensure the laboratory included the name of the laboratory where the test was performed on 5 out of 11 test reports reviewed. A. Review of 5 of 11 patient test reports showed all 5 Throat Culture test reports did not include the name of the laboratory where the testing was performed. The following Throat Culture test reports by accession number were reviewed: #797764, 807008, 819394, 820103, and 831597. B. Interview with the Technical Consultant on the CMS form 209 on January 12, 2021 at 1240 in the patient room confirmed the test reports were missing the name of the facility. -- 4 of 4 --