Internal Medicine & Pediatric Clinic Of New Albany

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency records and interview with the technical consultant (TC), testing personnel (TP) #1 and TP #2 as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to verify the accuracy of the drugs of abuse (DOA) testing at least twice annually for two of two verifications of accuracy. Findings Include: 1. Review of the proficiency records from 2023 and 2024, revealed the DOA panel had not been verified as accurate for the year 2023. Two of two verifications of accuracy had not been performed for the DOA panel. The drugs of abuse (DOA) panel include the following: Amphetamines, Benzodiazapine, Opiates, Methadone, Barbiturates, Cocaine, THC (Tetrahydrocannabinol), PCP (Phencyclidine), and Oxycodone 2. During an interview with the TC, TP #1, and TP #2 (by phone) on 5/22/2024 at 4:00 pm, confirmed the accuracy had not been verified on the drugs of abuse panel performed on the Vitros 5600 chemistry analyzer. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a 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 -- minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the Ortho 5600 chemistry analyzer records including quality control, maintenance and calibration records and confirmation with the technical consultant (TC) and testing personnel (TP)#2 as listed on the CMS 209 personnel form, the laboratory failed to document as performed, the calibration verification on the Ortho 5600 chemistry analyzer every 6 months for Vitamin D, Vitamin B12, TIBC, LDL. Two of two calibration verifications were not performed during the timeframe reviewed. Findings include: 1. Calibration verification is required every 6 months on any assay which is calibrated with less than 3 levels of calibration material. These 4 tests mentioned only have 2 calibrators provided by the manufacturer to use during calibration. 2. Review of calibration records since installation of the Ortho 5600 chemistry analyzer in 3/2023 through the day of survey, revealed the laboratory failed to perform calibration verification every 6 months on Vit D, Vit B12, TIBC and LDL. 3. The TC and TP#2 (by phone) confirmed in an interview on 5/22/2024 at 1:00 p.m. that the calibration verification was not performed at the appropriate timeframe or frequency during the period of 3/2023 through 5/22/2024. Two of two calibration verifications required were not performed and exceeded the 6-month timeframe required by the manufacturer. -- 2 of 2 --

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 surveyor review of proficiency testing (PT) records for 2020, 2021 and 2022, surveyor review of the (CMS) Centers for Medicare & Medicaid Services 209 personnel form and confirmation by testing personnel (TP) #1 and #2 at 3:30 p.m. on 8 /25/22, the laboratory failed to allow TP who routinely perform CBC testing on the patient samples to participate in proficiency testing events for 2020, 2021 and 2022. Findings include: 1. Review of proficiency records since 12/3/2020 revealed the 3rd event for 2020, 1st, 2nd, and 3rd events for 2021, and 1st and 2nd events for 2022 were all performed by TP #1 and #2. 2. In an interview with TP #1 and TP #2 at 3:00 p.m. on 8/25/22 confirmed that CBC testing on patient samples is routinely performed by all testing personnel (TP #1 through #9) as listed on the CMS-209. 3. TP #3, #4, #5, #6, #7, #8, and #9 did not perform any proficiency testing for CBC in the years 2020, 2021 or 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 1 --

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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/24/2021, the laboratory has not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL (WBC) DIFFERENTIAL: PROFICIENCY TESTING PROVIDER: American Proficiency Institute WHITE BLOOD CELL (WBC) DIFFERENTIAL: Year 2020 2nd Event 32% Year 2021 1st Event 28% Scores less than 80% for this analyte or parameter 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 -- indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/24/2021, the laboratory has not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL (WBC) DIFFERENTIAL: PROFICIENCY TESTING PROVIDER: American Proficiency Institute WHITE BLOOD CELL (WBC) DIFFERENTIAL: Year 2020 2nd Event 32% Year 2021 1st Event 28% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the Centers of Medicare and Medicaid Services (CMS) database proficiency testing report and confirmation by testing personnel at 1:30 pm on 12/3 /20, the laboratory failed to enroll and participate in an HHS approved proficiency testing (PT) program for CKMB (Creatinine Kinase) performed on the Biosite Triage Meter. The laboratory must enroll and participate in an approved program for the specialties performed by the laboratory. Findings Include: 1. Based on review of the CMS data base proficiency report, the laboratory did not enroll in an approved program for CKMB. There were no scores for CKMB for the year 2020. The lab began testing patients in March 2020. 2. Interview with testing personnel at 1:30 pm on the day of survey (12/3/20) confirmed that the laboratory was not enrolled in proficiency for CKMB testing. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: A. Based on review of laboratory proficiency records, TOX drug screen records from installation of the Biosite Triage Meter (3/4/20) until the day of survey (12/3/20) and interview with testing personnel at 1:30 pm on the day of survey, the laboratory failed to verify the accuracy of myoglobin, troponin and the TOX drug screen (AMP, mAMP, Bar, Bzo, Coc, EDDP, Opi, TCA, THC) testing at least twice annually since the laboratory installed and began testing on the Biosite Triage Meter on 3/4/20. The laboratory must verify the accuracy of testing that is not included in subpart I of the CLIA regulations Findings Include: 1. Review of the cardiac marker (Troponin, Myoglobin) records on the Biosite Triage Meter from 3/4/20 until 12/3/20 revealed the cardiac markers had not been verified for accuracy twice a year. 2. Review of the Tox Drug Screen records (amphetamines, metamphetamines, barbiturates, benzodiazepines, cocaine, EDDP"methadone", opiates, TCA"tricyclic antidepressant", THC"tetrahydrocannabinol") performed on the Biosite Triage Meter from 3/4/20 until 12/3/20 revealed the Tox Drug screen had not been verified for accuracy twice a year. 3. Interview with staff at 1:30 pm on 12/3/20 confirmed that accuracy had not been verified on the cardiac panel (Troponin and Myoglobin) or the Tox drug screen since testing began. B. Based on review of the laboratory proficiency records, Alere Afinion procedure manual, microalbumin /Creatinine records from installation of the Alere Afinion (1/10/19) until the day of survey (12/3/10), and interview with staff at 2:00 pm on the day of survey, the laboratory failed to verify the accuracy of microalbumin /Creatinine testing at least twice annually since the laboratory began testing and installation of the Alere Afinion 1/10/19. The laboratory must verify the accuracy of testing that is not included in subpart I. Findings Include: 1. Microalbumin/Creatinine records from installation on the Alere Afinion (1/10/19) until the day of survey did not include any verification for accuracy. Review of proficiency records for 2019 and 2020 indicated not proficiency testing had been performed for microalbumin /Creatinine which would have verified accuracy. 2. Interview with testing personnel at 2:00 pm on 12/3/20 confirmed the accuracy had not been verified for Microalbumin /Creatinine on the Alere Afinion analyzer. 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) (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: A. Based on review of testing records for the Biosite Triage Meter Tox drug screen, Cardiac panel and lack of documentation of verification of performance specifications, and interview with testing personnel on 12/3/20 at 11:00 am, the laboratory failed to ensure that performance specifications were verified before reporting patient test results. The lab started using this analyzer on 3/4/20. Findings: 1. No documentation of verification of performance for the Tox Drug screen (AMP, mAMP, Bar, Bzo, Coc, EDDP, Opi, TCA, THC) was available for review on the day -- 2 of 6 -- of survey. 2. No documentation of verification of performance for the Cardiac (myoglobin, CKMB, troponin) panel was available for review on the day of survey. 2. Interview with testing personnel on 12/3/20 at 11:00 am revealed no verification of performance specifications was completed on cardiac or TOX drug screens before testing patients. B. Based on review of testing records for the Alere Afinion microalbumin, lack of the documentation of verification of performance specifications. and interview with testing personnel on 12/3/20 at 11:00 am, the laboratory failed to ensure that performance specifications were verified before reporting patient test results. The lab started testing on this analyzer 1/10/19. 1. No documentation of verification of performance for the Microalbumin on the Alere Afinion was available on the day of survey. 2. Interview with testing personnel on 12/3 /20 at 11:00 am revealed no verification of performance specifications was completed on Microalbumin before testing patients. 3. The Abbott Afinion procedure verification procedure requires both precision and accuracy study be verified for the Microalbumin and Creatinine. It states the laboratory is responsible for verifying that reproducibility can be established during the verification process. 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 the Sysmex XN 330 hematology analyzer maintenance records from its installation on 1/21/20 until the day of survey (12/3/20) and interview with testing personnel at 2:30 pm on the day of survey, the laboratory failed to document as performed the weekly, monthly and quarterly maintenance on the Sysmex XN 330 analyzer as required by the manufacturer. Findings include: 1. Review of the Cell Dyn 1800 records revealed the following maintenance had only been documented as performed one time on the hematology analyzer since installation on 1/21/2020. Weekly (performed on 1/3/20) - Clean SRV tray Monthly (no documentation of performance) - a. Clean RBC and WBC transducer b. Clean waste chamber Quarterly (performed on 1/3/20) - Clean sample rotor valve 2. Interview with the testing personnel on the day of survey at 2:30 pm confirmed maintenance was not documented as performed on the Sysmex maintenance log provided by the manufacturer. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless -- 3 of 6 -- the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of Biosite Triage Meter records from installation on 3/20/20 through the day of this survey on 12/3/20 and confirmation with testing personnel at 3:00 pm on 12/3/20, the laboratory failed to perform calibration verification on the Biosite Triage Meter chemistry analyzer every 6 months for the cardiac panel and Tox drug screen. Findings include: 1. Review of the laboratory Biosite Triage Meter Tox Drug screen records for: AMP, mAMP, Bar, Bzo, Coc, EDDP, Opi, TCA, THC from 3/20 /20 until the day of survey revealed no calibration verification had been performed on the Tox Drug screen tests every 6 months as required by the manufacturer. 2. Review of the laboratory Biosite Triage Meter Cardiac panel records for: CKMB, troponin, myoglobin from installation on 3/20/20 revealed that a calibration verification was not performed on the cardiac panel every 6 months as required by the manufacturer. 3. Interview with testing personnel at 3:00 pm on the day of survey confirmed that calibration verification was not performed for Tox Drug screen tests or the Cardiac Panel every 6 months as required by the manufacturer. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) and patient records for the Alere Afinion Microalbumin/Creatinine from 9/22/20 through 12/3/20, lack of documentation of an IQCP (Individualized Quality Control Plan), and an interview with the laboratory general supervisor (GS) at 3:30 on the day of survey, the laboratory failed to include a positive and negative control on each day of patient testing for Microalbumin /Creatinine. Findings Include: 1. Interview with the laboratory GS on the day of survey (12/3/20) at 3:30 pm confirmed that laboratory testing personnel were not performing QC each day of Microalbumin/Creatinine testing on the Alere Afinion but per lot number change. 2. Review of the QC and patient Microalbumin/Creatinine log from 9/22/20 through 12/3/20 revealed a total of 13 patient specimens were tested and results reported with no documentation of the performance of 2 levels of controls each day of testing. The following days patients were tested but no QC documented as performed: 10/27/20 - 2 patients tested 11/5/20 - 1 patient tested 11/12/20 - 2 patients tested 11/20/20 - 3 patients tested 11/24/20 - 1 patient tested 11/25/20- 1 patient tested 11/27/20 - 2 patients tested 12/2/20 - 1 patient tested -- 4 of 6 -- D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records, Centers of Medicare and Medicaid Services (CMS) database proficiency testing report and confirmation with testing personnel at 3:30 pm on 12/3/20, the laboratory director failed to ensure the laboratory was enrolled and participated in an HHS approved proficiency testing (PT) program for CKMB performed on the Biosite Triage Meter for the year 2020. Findings include: 1. Observation of the CMS database proficiency testing report revealed no scores for 2020. 2. Review of laboratory records since installation of the Triage Meter on 3/4/20 through the day of survey, 12/3/20, revealed no evidence of proficiency testing participation prior to survey. 3. Interview with testing personnel at 3:30 pm on day of survey revealed the laboratory did not enroll in proficiency for the year 2020 for CKMB on the Biosite Triage meter. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on laboratory and installation records for the Biosite Triage Meter and the Alere Afinion and interview with Testing Personnel at 2:00 pm on the day of the survey (12/3/20), the technical consultant (TC) did not ensure that test performance was established and verified for the Microalbumin/Creatinine, cardiac panel and drug screen test procedures. Findings Include.: 1. Review of installation records for the Biosite Triage Meter did not reveal verification or test performance was established for the Tox Drug Screen: AMP, mAMP, Bar, Bzo, Coc, EDDP, Opi, TCA, THC 2. Review of installation records for the Biosite Triage Meter did not reveal verification or test performance was established for the Cardiac Panel: Myoglobin, CKMB, Troponin 3. Review of the installation records for the Alere Afinion did not reveal verification or test performance was established for the Microalbumin/Creatinine. 4. Interview with testing personnel at 2:00 pm confirmed no verification of performance was performed for the Microalbumin/Creatinine, drug screens or cardiac panel and ensured by the TC. 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 -- 5 of 6 -- annually, after the first year. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records from the last survey on 6/6/18 through the day of survey on 12/3/20, the Centers of Medicare and Medicaid Services (CMS) 209 personnel form, and lack of documentation for review, the technical consultant (TC) failed to evaluate annually and document the performance of laboratory testing personnel (TP) #3 and #16 responsible for laboratory testing. An annual evaluation/competency must be performed each year of employment by the technical consultant. Findings include: 1. Review of TP #3 personnel records since the last survey revealed the initial training/competency was performed on 10/22/19 by the TC. The 6 month or biannual evaluation/competency was performed on 4/22/20 by the TC. There was no annual evaluation documented for 2020. 2. Review of TP #16 personnel records since the last survey revealed the initial training/competency was performed on 10/21/18 by the TC. The 6 month or biannual evaluation/competency was performed on 4/21/19 by the TC. There was no annual evaluation documented for 2020. -- 6 of 6 --