Pediatric Consultants Of Troy

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 record review and interview with Testing Personnel #6, the laboratory failed to establish a competency assessment policy to assess its laboratory employees for two (October 2022 to October 2024) of two years reviewed. Findings include: 1. A review of the laboratory's competency assessment documentation revealed a lack of competency assessments for Technical Consultant #2. 2. The surveyor requested the competency assessments for Technical Consultant #2 and the laboratory's competency assessment policy on 10/9/24 at 10:58 am and they were not made available. 3. An interview on 10/9/24 at 10:58 am with Testing Personnel #6 confirmed the laboratory had not established a competency assessment policy. 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. 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 -- This STANDARD is not met as evidenced by: . Based on observation, record review, and interviews, the laboratory failed to include patient last names on test reports for three (Patient #2, Patient #3, and Patient #11) of eleven patient test reports reviewed. Findings include: 1. The surveyor observed Testing Personnel #2 collect Patient #11's specimen and perform Complete Blood Count (CBC) testing on 10/9/24 at 9:05 am. Prior to sampling the patient's specimen into the CBC analyzer, Testing Personnel #2 entered the patient's identification number and first name into the analyzer manually. When the test report was generated after testing, the patient identifiers only included the identification number and first name. Shortly after the report was printed, Testing Personnel #2 initialed the report, and the ordering provider reviewed and signed the report. 2. An interview on 10/9/24 at 9:15 am with Testing Personnel #2 confirmed it was laboratory practice to include only the first name and patient identification number on the test report initially. About twice a day, the printed reports from that day have stickers including the full patient's name, date of birth, and identification number affixed to the report and are scanned into the appropriate patient charts. 3. A review of patient test reports revealed the following patient test reports did not include the sticker with the full name, date of birth, and identification number: a. Patient #2 with CBC testing performed on 6/12/24. b. Patient #3 with CBC testing performed on 5/10/24. 4. A review of patient test reports revealed the following patient test reports with incorrect patient identification numbers manually entered into the instrument and generated on the test report: a. Patient #7 with CBC testing performed on 7/18/23. b. Patient #8 with CBC testing performed on 6/13/23. 5. An interview on 10/9/24 at 9:45 am with Testing Personnel #6 confirmed providers review test reports before stickers with additional patient information are added to patient test reports. Discrepancies in patient identification numbers would be discovered when stickers are generated at the time reports are scanned into the chart.

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 record review and interview, the laboratory failed to retain the original instrument patient printouts for the Medonic M-Series hematology analyzer for two (#5 and #6) of ten patient charts audited. Findings include: 1. On December 20, 2018 at 12:25 PM, record review for patient charts audited revealed the laboratory did not retain the Medonic M-series hematology instrument printout with the patient's results for two years. 2. During the interview on December 20, 2018 at 12:25 PM, testing personnel #1 as listed on the CMS-209 confirmed patient results from the hematology instrument were not retained for two years. 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. 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to establish a system to ensure the manually entered hematology testing was entered into the patient's electronic medical records (EMR) correctly for two (#6 and #10) of ten patient charts audited. Findings include: 1. On December 20, 2018 at 12:25 PM, record review of patient charts audited revealed the final results in the patient's EMR file did not match the monthly log printed with patient results as follows: a. #6 - the absolute counts for the lymphocytes, monocytes, and the granulocytes were switched with the percent count values. b. #6 - the percent counts for the lymphocytes, monocytes, and the granulocytes were switched with the absolute count values. c. #10 - the white blood cell count, granulocyte absolute, red blood cell count, hemoglobin, hematocrit, RDW%, and the platelet count had values not listed on the monthly log. 2. On December 20, 2018 at 12:25 PM, testing personnel #1 as listed on the CMS-209 confirmed the laboratory did not have a measure in place to ensure the correct results are entered into the EMR system. . D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to detect an incorrect laboratory test result reported out for one (#6) of ten patient charts audited. Findings include: 1. On December 20, 2018 at 12:25 PM, record review revealed for one patient chart audited the final result enetered in the electronic medical records (EMR) system did not match the results on the monthly patient log from the hematology Medonic M-series instrument as follows: a. #6 - the absolute counts for the lymphocytes, monocytes, and the granulocytes were switched with the percent count values. b. #6 - the percent counts for the lymphocytes, monocytes, and the granulocytes were switched with the absolute count values. 2. During the interview on December 20, 2018 at 12:25 PM, testing personnel #1 as listed on the CMS-209 confirmed incorrect results were entered into the patient's EMR. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require