Pediatric Consultants Of Troy

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview, the laboratory failed to follow its Bayer & Bayer Contour glucometer manufacturer's instructions for 1 of 1 patient test observed. Findings include: 1. The surveyor observed Testing Personnel #6 on 11 /20/23 at 2:05 pm collect and perform Complete Blood Count (CBC) testing using a capillary puncture specimen collected in an EDTA, lavender-top microtainer tube. Once the CBC testing concluded, Testing Personnel #6 looked in the cabinets near the CBC analyzer and Testing Personnel #7 gave the Bayer & Bayer Contour glucometer to Testing Personnel #6. Testing Personnel #6 proceeded to perform a blood glucose test using the glucometer and the patient's EDTA capillary blood specimen. 2. The surveyor requested the laboratory's Bayer & Bayer Contour glucometer manufacturer's instructions on 11/20/23 at 2:05 pm and it was not made available. 3. A review of the laboratory's "Controls and Testing for Glucose" policy revealed a section titled "TESTING" stating, "Wipe first drop of blood off and use second drop for testing." 4. A review of the Bayer & Bayer Contour Blood Glucose Monitoring System manufacturer's instructions revealed a lack of specification for using EDTA anticoagulated blood samples in glucose testing. 5. An interview on 11/20/23 at 4:05 pm with Technical Consultant #2 and Testing Personnel #7 that Testing Personnel #6 had not followed manufacturer's instructions when performing patient testing using the Bayer & Bayer Contour glucometer. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 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 record review and interview with Technical Consultant #2, the laboratory failed to have the individual testing the proficiency testing samples and the Laboratory Director attest to the integration of samples into the patient workload using the laboratory's methods for 4 (2022 Event 3, 2023 Events 1-3) of 5 proficiency testing events reviewed. Findings include: 1. A review of the laboratory's American Association of Bioanalysis and Medical Laboratory Evaluation proficiency testing records revealed a lack of attestation statement from the testing personnel and Laboratory Director attesting to the integration of samples into the patient workload using the laboratory's methods for the following testing events: a. 2022 Event 3 b. 2023 Event 1 c. 2023 Event 2 d. 2023 Event 3 2. An interview on 11/20/23 at 2:55 pm with Technical Consultant #2 confirmed the laboratory had not attested to the integration of samples into the patient workload using the laboratory's methods for the testing events listed above. 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 observation, record review, and interview, the Laboratory Director failed to provide overall management and direction to the laboratory. Refer to D6004. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview, the Laboratory Director failed to ensure testing personnel were competent, could provide accurate test results, and were assuring compliance. Refer to D1001. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES -- 2 of 3 -- 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #2, the Technical Consultant failed to evaluate testing personnel at least semiannually in their first year of testing for 1 (Testing Personnel #4) of 2 new testing personnel hired since the previous survey. Findings include: 1. A review of testing personnel competency assessments revealed Testing Personnel #4 was hired 11/1/22 and had their competency assessed for Complete Blood Count testing on 10/11/23. 2. An interview on 11/20/23 at 3:59 pm with Technical Consultant #2 confirmed Testing Personnel #4 had not been assessed at least semiannually during their first year of testing patient specimens. 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 record review and interview with Technical Consultant #2, the laboratory failed to evaluate testing personnel at least annually for 2 (Testing Personnel #1 and #7) of 7 testing personnel listed on Form CMS-209. Findings include: 1. A review of testing personnel competency assessments for Complete Blood Count testing revealed the following personnel had not been assessed in over one year: a. Testing Personnel #1 was last assessed on 8/12/22. b. Testing Personnel #7 was last assessed on 2/23/22. 2. An interview on 11/20/23 at 4:02 pm with Technical Consultant #2 confirmed the testing personnel listed above had not had their competency assessed at least annually. -- 3 of 3 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Based on record review and interviews, the laboratory failed to establish policies and procedures to ensure positive identification of patient specimens at the time of collection for 2 (March 2020 to March 2022) of 2 years. Findings include: 1. The surveyor observed Testing Personnel #3 (TP3) perform a capillary blood collection for Complete Blood Count (CBC) testing on 3/22/22 at 10:08 am. TP3 had a plastic cup labeled with the patient first name and medical record number prior to entering the patient room. TP3 did not verify the patient prior to collecting the sample for testing. 2. TP3 confirmed the patient was not verified during the collection of the patient sample on 3/22/22 at 10:08 am. 3. A review of the laboratory's policies and procedures revealed a lack of a policy to ensure positive identification of patient specimens. 4. An interview on 3/22/22 at 11:10 am with the clinical manager confirmed the laboratory did not establish policies and procedures to ensure positive patient identification of patient 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 1 --

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: . A. Based on record review and interview with Testing Personnel (TP) #1, the laboratory failed to retain the hematology maintenance logs for 12 (May to December 2018 and January to April 2019) of 24 months reviewed. Findings include: 1. Record review of the M-series Medonic hematology analyzer maintenance log revealed a lack of documentation of the monthly maintenance for 12 (May to December 2018 and January to April 2019) of 24 months reviewed. 2. When queried on 3/11/2020 at 11: 41 am, TP1 stated the maintenance was completed but the documentation was not retained. 3. During the interview on 3/11/202 at 11:41 am, TP1 confirmed the laboratory did not retain the monthly maintenance log for 2 years. B. Based on record review and interview with Testing Personnel (TP) #1, the laboratory failed to retain the hematology calibration documents for 2 (April and October 2018) of 4 calibrations performed in 2018 and 2019. 1. Record review of the M-series Medonic hematology calibration documents revealed the laboratory did not retain 2 (April and October in 2018) of 4 calibrations performed in 2 years. 2. When queried on 3/11/2020 at 1:16 pm, TP1 stated the calibrations were performed and the documents were not retained. 3. During the interview on 3/11/2020 at 1:16 pm, TP1 confirmed the calibration documents were not retained for 2 years. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must 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 -- meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #1, the laboratory failed to meet the requirements for the specialty in Hematology. Findings include: 1. The laboratory failed to establish a system to ensure the manually transcribed hematology complete blood cell count (CBC) test values were accurately reported from point of entry to the final report. Refer to D5801. 2. The laboratory failed to document the specimen collection date and time for the hematology complete blood cell count (CBC) result in the electronic medical record (EMR). Refer to D5805. 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. This STANDARD is not met as evidenced by: . Based on document review and interview with Testing Personnel (TP) #1, the laboratory failed to establish a system to ensure the manually transcribed hematology complete blood cell count (CBC) test values were accurately reported from point of entry to the final report in the electronic medical record (EMR) system for 1 (#9) of 13 patient charts audited. Findings include: 1. Record review revealed for 1 (#9) of 13 patient charts audited the manually transcribed results for the CBC did not match the instrument generated report as follows: a. white blood cell count i. instrument report = 2.6 ii. manually transcribed = 4.6 b. granulocytes i. instrument report = 1.3 ii. manually transcribed = 2.3 c. red blood cell count i. instrument report = 1.69 ii. manually transcribed = 4.69 d. hemoglobin i. instrument report = 5.1 ii. manually transcribed = 15.0 e. hematocrit i. instrument report = 14.5 ii. manually transcribed = 44.5 f. red blood cell distribution width % i. instrument report = 10.6 ii. manually transcribed - 35.1 g. platelet i. instrument report = 105 ii. manually transcribed = 155 2. On 3/11/2020 at approximately 1:30 pm when requested, TP1 was unable to provide documentation to show the transcribed manual results entered into the EMR system were valid as no repeat testing was available. 3. During the interview on 3/11 /2020 at approximately 1:30 pm, TP1 confirmed the transcribed results in the EMR did not match the results generated from the analyzer and no repeat testing or redraw of the specimen was documented. 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 -- 2 of 4 -- 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 record review and interview with Testing Personnel (TP) #1, the laboratory failed to document the specimen collection date and time for the hematology complete blood cell count (CBC) result in the electronic medical record (EMR) for 8 (2, 4-5, 7- 9, 11, and 13) of 13 patient charts audited. Findings include: 1. Record review for 8 (2, 4-5, 7-9, 11, and 13) of 13 patient charts audited the collection date and time was not manually entered into the EMR final transcribed result. 2. On 3/11/2020 at approximately 1:40 pm when queried, TP1 acknowledged the collection date and time was not manually entered into the EMR system. 2. During the interview on 3/11/2020 at approximately 1:40 pm, TP1 confirmed the collection date and time was not documented in the EMR system for the manually transcribed CBC results. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP)#1, the laboratory failed to provide the educational requirements for 1 (#7) of 11 testing personnel who perform the moderately complex hematology testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #1, the laboratory failed to ensure that all testing personnel met the educational requirements at 493.1423 for 1 (#7) of 11 testing personnel as listed on the CMS-209 performing moderately complex hematology testing. Findings include: 1. On 3/11/2020 at 9:00 -- 3 of 4 -- AM, record review for 1 of 11 testing personnel credentials revealed the educational requirements for performing moderately complex hematology testing was not met. 2. During the interview on 3/11/2020 at 9:00 AM, TP1 as listed on the CMS-209 confirmed the educational requirements were not met. 3. On 3/11/2020 at 9:00 am, the laboratory was given 7 additional days to supply the necessary educational documents. The documents were not received. -- 4 of 4 --

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 Medonic hematology analyzer daily patient log for 25 (July 1 -23 and August 1 - 14) of 62 calendar days in 2017 for two years. Findings include: 1. On January 24, 2018 at 2:30 p.m., record review of the Medonic daily patient logs revealed for 25 of 62 calendar days in 2017 the laboratory did not retain the patient's complete blood cell count (CBC) records for two years. 2. During the interview on January 24, 2018 at 2:30 p. m., testing personnel #1 as listed on the CMS-209 confirmed the daily patient logs were not retained for two years. 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, the laboratory failed to ensure written competency policies were implemented for one (#10) of 12 testing personnel in performing the hematology complete blood cell count testing in 2017. Findings include: 1. On January 24, 2018 at 10:05 a.m., record review for one of 12 testing 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 -- personnel revealed the initial competency assessment was not performed and documented in 2017. 2. During the interview on January 24, 2018 at 10:05 a.m., testing personnel #1 and #5 confirmed the initial competency assessment was not completed. ***Repeat Deficiency from June 26, 2014 survey*** 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 record review and interview, the laboratory failed to perform the hematology calibration procedures at least every six months for one (2017) of two years reviewed. Findings include: 1. On January 24, 2018 at 11:30 a.m., review of the calibration data for the Medonic hematology analyzer revealed the laboratory did not perform and document the calibration procedure every six months for one of two years. 2. On January 24, 2018 at 11:30 a.m. when queried, testing personnel #1 as listed on the CMS-209 was not able to provide the surveyor with the documentation to demonstrate the calibrations had been performed every six months in 2017 for the complete blood cell count. 3. During the interview on January 24, 2018 at 11:30 a.m., testing personnel #1 confirmed the calibrations for the hematology analyzer were not performed and documented every six months in 2017. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to maintain a record system that included the identity of the testing personnel for one (#8) of ten patient charts audited for the hematology complete blood cell count (CBC) testing in 2016 and 2017. Findings include: 1. On January 24, 2018 at 2:15 p.m., record review for one of ten patient charts audited revealed the laboratory did not have a record system in place that included the identity of the testing personnel who performed and -- 2 of 4 -- documented the hematology testing. 2. During the interview on January 24, 2018 at 2: 15 p.m., testing personnel #1 as listed on the CMS-209 confirmed the testing personnel identity was not documented. 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 record review and interview, the laboratory failed to provide 1) the hematology complete blood cell count (CBC) units of measurement on the final report in the patients electronic medical records (EMR) for seven (July 2017 to January 24, 2018) of seven months and 2) the final paper report for one (#4) of ten charts audited in the patient's paper chart. Findings include: 1. On January 24, 2018 at 10:37 a.m., record review for seven of seven months the patient's final CBC result in the EMR system revealed the units of measurement were not included in the final report. 2. On January 24, 2018 at 2:00 p.m., record review revealed for one of ten patient charts audited the laboratory did not have a copy of the final report in the patient's paper chart. 3. During the interview on January 24, 2018 at 10:37 a.m. and 2:00 p.m., with testing personnel #1 and #5 as listed on the CMS-209 confirmed the units of measurement for each parameter of the CBC were not reported on the patient's final report in the EMR system and the final paper report was not in the patient's paper chart . 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