Children's Clinic Pa Of West Tennessee, The

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 observation of the laboratory, review of the laboratory's personnel policy, testing personnel records and patient records, and interview with the laboratory lead, the laboratory failed to follow its' own testing personnel competency procedures in 2020, 2021 and 2022 for moderately complex patient testing for four of four testing personnel, twelve of twelve competencies performed. The findings include: 1. Observation of the laboratory on 02/08/2023 at 8:15 am revealed the following moderately complex test systems in use for patient testing: Beckman Coulter AcT Diff Complete Blood Count (CBC) instrument, a microscope in use for performing urine microscopy and an Advanced Instrument BR-2 instrument used for performing total and direct bilirubin on neonates. 2. Review of the laboratory's policy titled "Personnel Competency" revealed the following statement: "Those personnel who perform testing on patient specimens are required to have the six required procedures in their competency assessment." All six required elements were included in the policy. 3. Review of testing personnel records and patient testing records revealed the following: Testing person #1: No documentation of problem solving on three of three annual competencies performed in 2020, 2021, and 2022 for the CBC and urine microscopics in 2020, 2021 and 2022, and for the bilirubin testing in 2020. Testing person #2: No documentation of problem solving on annual competency performed for CBC, Urine microscopics, and bilirubin in 2020, no problem solving for CBC and urine microscopics for the annual competency assessment performed in 2021, and no annual competency for urine microscopy performed for the 2022 annual competency with patient testing for urine microscopics performed by testing person #2 in 2022 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 -- (patient 196093 on 03/24/22 and patient 89305 on 11/14/22.) Testing Person #3: No documentation of Record Review or blind testing for CBC and urine microscopic for annual competency performed in 2020; No documentation of problem solving for CBC, urine microscopics, or bilirubin for annual competency in 2020. No documentation of record review, blind testing or problem solving for CBC, urine microscopics, or bilirubin for the annual competency done in 2021; no documentation of problem solving for the competency performed in 2022 for the CBC and urine microscopic. Testing Person #4: No documentation of record review, QC review, blind testing or problem solving for CBC and urine microscopic on initial competency done on 06/30/21; no problem solving for interim competency done on 09/28/21 for CBC and urine microscopic; no problem solving for annual competency done on 09/23 /22 for CBC and urine microscopic. 4. Interview with the laboratory lead on 02/07/23 at 1:30 pm confirmed the laboratory failed to follow its' own testing personnel policies in 2020, 2021, and 2022 for four of four testing personnel and twelve of twelve competencies performed. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records and interview with the laboratory lead, the laboratory failed to evaluate non-graded proficiency testing results for one of one ungraded PT results for 2022 event two. The findings include: 1. Review of the laboratory's proficiency testing records revealed a non- graded score for slide CMP-14 (urine sediment) for 2022 event two. There was no documentation the ungraded score had been evaluated for accuracy. 2. Interview with the laboratory lead on 02/07/23 at 1:00 pm confirmed the laboratory did not evaluate non-graded PT scores for one of one result that was not scored in 2022. She further stated she did not know the non-graded scores had to be evaluated. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for the specialty of chemistry and the bilirubin analyte for 2020 event two and 2021 event one, resulting in the first unsuccessful PT performance for the chemistry specialty and the bilirubin analyte. (Refer to D2096 and D2097) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and the laboratory's proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the bilirubin analyte in two out of three PT events, resulting in the first unsuccessful PT occurrence for the bilirubin analyte. The findings include: 1. Review of the CMS 155 report revealed the following for the bilirubin analyte: 2020 event two scored as 0% 2021 event one scored as 20% 2. Review of the laboratory's proficiency testing records for 2020 event two revealed the bilirubin analyte was scored as 0% for "Results for this kit were not received." 3. Review of the laboratory's proficiency testing records for 2021 event one revealed sample numbers NB-01, NB-02, NB-04 and NB-05 scored as unacceptable, resulting in an overall score of 20% for the bilirubin analyte and the first unsuccessful PT occurrence for the bilirubin analyte. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and the laboratory's proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the chemistry specialty in two out of three PT events, resulting in the first unsuccessful PT occurrence for the chemistry specialty. The findings include: 1. Review of the CMS 155 report revealed the following for the chemistry specialty: 2020 event two scored as 0% 2021 event one scored as 20% 2. Review of the laboratory's proficiency testing records for 2020 event two revealed the chemistry specialty was scored as 0% for "Results for this kit were not received." 3. Review of the laboratory's proficiency testing records for 2021 event one revealed the specialty of chemistry was scored as 20%, resulting the first unsuccessful PT occurrence for the chemistry specialty. -- 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 the laboratory procedure manual, competency assessment documents, and interview with the lead testing personnel, the laboratory failed to have a policy/procedure for testing personnel competency assessment in 2018 and 2019. The findings include: 1) Review of the laboratory procedure manual revealed no policy/procedure for testing personnel competency assessment. 2) Review of the laboratory's Centers for Medicare and Medicaid Services form 116 (CMS 116) revealed the laboratory performs the following testing: Total and Direct Bilirubin, Wet Prep, KOH prep, Urine Microscopy, and Complete Blood Count (CBC). 3) Review of the laboratory's competency assessment form revealed competency assessments performed, with no indication of which test systems the competency was performed for. 4) Interview with the lead testing personnel on October 11, 2019 confirmed the laboratory does not have a policy/procedure for testing personnel competency and the current competency assessment form does not indicate which test systems competency was performed for. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) 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 -- (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory records, and interview with the lead testing personnel, the laboratory failed to verify the performance of the Advanced Instruments Bilirubinometer BR2 instrument used for performing Total and Direct Bilirubin in 2018. The finding include: 1) Observation of the laboratory on October 11, 2019 at 8:45 am revealed the Advanced Instruments Bilirubin Stat- Analyzer (serial number 17040348C) on the counter in use for patient testing for total and direct bilirubin. This instrument serial number was new since the last survey. 2) Review of laboratory records revealed no verification of performance specifications for the new bilirubin instrument were present. 3) Interview with the lead testing personnel confirmed no records were available verifying the performance specifications for the Advanced Instruments Bilirubinometer. The laboratory uses the Advanced Instrument Bilirubinometer for patient testing for total and direct bilirubin, and began using the instrument sometime early 2018. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D0000 A revisit survey was conducted on Childrens Clinic PA, The for all previous deficiencies cited on November 16, 2017. All deficiencies have been corrected, and no new noncompliance was found. The facility is in compliance with all regulations surveyed. 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 --