St Dominic's Internal Medicine

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 American Proficiency Institute and the CASPER report 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 9/23 /2022, the laboratory failed to maintain satisfactory performance in three of four testing events (2021- Event 2 and 2022- Events 1 & 2) resulting in unsuccessful 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 -- performance in Hematology for the analyte White Blood Cell Differential (WBC Diff). Refer to D2130. 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 American Proficiency Institute and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 9/23 /2022, the laboratory has not successfully performed proficiency testing for WBC Diff in three of four testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D /0155D revealed the laboratory scored the following for WBC Diff: : Year 2021-2nd Event: 67% Year 2022-1st Event: 67% Year 2022-2nd Event: 20% 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 9/23 /2022, the laboratory director failed to provide overall management and direction for ensuring Hematology proficiency testing was tested for three out of four events as required under Subpart H. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER report 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 9/23 /2022, the laboratory director failed to ensure Hematology proficiency testing was tested as required under Subpart H. The laboratory failed to maintain satisfactory -- 2 of 3 -- performance in three of four testing events (2021-Event 2 and 2022-Events 1 and 2) resulting in the subsequent unsuccessful performance for WBC Diff. Refer to D2130. -- 3 of 3 --

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 5/26/22, the laboratory has not successfully performed 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 2021 2nd Event 67% Year 2022 1st Event 67% Scores less than 80% for this analyte or parameter indicate failure for 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 -- 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 5/26/22, the laboratory has not successfully performed 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 2021 2nd Event 67% Year 2022 1st Event 67% 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 D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory proficiency testing (PT) records from 6/20 /2019 through 10/26/2021 and confirmation with the technical consultant (TC) at 12: 30 p.m. on 10/26/21, the laboratory failed to retain all proficiency testing records. Findings include: 1. Observation of proficiency testing records revealed the laboratory did not retain the following: a. Signed attestation statements for 2nd and 3rd events of 2019 and 1st event of 2020 b. Graded results from the PT provider for 1st event of 2020 c. Analyzer printouts for 2nd and 3rd events of 2019 and 1st event of 2020 d. Documentation of PT record review for 2nd and 3rd events of 2019 and 1st event of 2020 2. Interview with the TC at 12:30 p.m. on 10/26/2021 confirmed previously listed proficiency records were not retained with the completion of each proficiency testing event. 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 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of temperature records from 11/29/17 through 6/20/19 and confirmation with the technical consultant at 10:55 a.m. on the day of survey 6/20/19, the laboratory failed to monitor and document the temperature and humidity of the room where the Sysmex XP 300 and Alfa Wassermann ACE Axcel were stored and operated. Findings include: Maintaining appropriate conditions according to the instructions of the manufacturer is essential for optimal test performance. A. The Sysmex XP 300 manufacturer's instructions state: 1. Operate the instrument at ambient temperature range between 15-30 degrees Celsius (C). Optimal room temperature is 23 degrees C. 2. Allow quality control (QC) material to come to room temperature at 18-25 degrees C for 15 minutes. 3. Store Cell Pack, Stromatolyser- WH, reagents and bleach at room temperature of 15-30 degrees C. 4. Operate the instrument with relative humidity ranges between 30% and 85% B. The Alfa Wassermann manufacturer's instructions state: 1. Operate analyzer at ambient room temperature between 15 degrees Celsius (C) and 26.7 degrees Celsius (C). 2. Operate analyzer in room with 20%-80% relative humidity (RH). D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on interview with testing personnel and observation of the Alfa Wassermann ACE Axcel chemistry controls, lot #1213UNCM (Level 1) and lot #937UECM (Level 2), in use by the laboratory on 6-20-19 at 10:30 a.m. and review of the manufacturer's instructions for the controls, the laboratory failed to follow the manufacturer's instructions for reconstitution and storage of the Alfa Wassermann chemistry controls in use with patient testing. Findings include: Manufacturer's instructions for the Alfa Wassermann chemistry controls state that the controls are stable for three days after reconstitution, when stored refrigerated. Observation of two vials of Alfa Wassermann chemistry controls, lot # 1213UNCM (Level 1) and lot # 937UECM (Level 2), in use on the day of the survey revealed there was no open date on the vials to ensure the controls were not used past the stability date. 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 surveyor review of preventive maintenance records, review of the Alfa Wassermann ACE Axcel Operator's manual, and interview with the technical consultant, the laboratory failed to perform and document the daily, weekly, monthly and bi-annual maintenance on the Alfa Wassermann ACE Axcel chemistry analyzer according to the manufacturer's instructions from 10-4-2018 through 6-20-2019. Findings include: The laboratory failed to document as performed the following required maintenance for the Alfa Wassermann ACE Axcel chemistry analyzer: Daily Maintenance 1. Remove condensation from reagent compartment 2. Touchplate cleaning 3. Exterior probe cleaning 4. Check probe alignment 5. Clean and condition ISE Weekly Maintenance 1. Clean ISE sample port 2. Clean exterior surface 3. Inspect air filters and clean, if necessary 4. Weekly touchplate cleaning Monthly Maintenance 1. Rinse probe and fluid lines with bleach 2. Clean cap assemblies 3. Calibrate table offset and sample delay switch 4. Clean ISE reference housing Bi- Annual Maintenance 1. Replace ISE pump tubing The technical consultant confirmed during an interview on 6-20-19 at 11:55 a.m. the testing personnel did not perform any maintenance on the ACE Axcel chemistry analyzer from the date of installation 10-4-2018 through the date of survey 6-20-2019. 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 -- 2 of 4 -- 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 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 surveyor review of laboratory records and interview with the technical consultant, the laboratory failed to perform and document the calibration verification procedure according to the manufacturer's instructions for the 16 analytes tested on the Alfa Wassermann ACE Axcel chemistry analyzer from 10-4-18 through 6-20-19. Findings include: 1. The laboratory had no records showing calibration verification performance for ALT, Albumin, Alkaline Phosphatase, AST, Total Bilirubin, Calcium, Chloride, Cholesterol, CO2, Creatinine, Glucose, Potassium, Sodium, Total Protein, Triglycerides and BUN. 2. The technical consultant confirmed on 6-20-19 at 11:40 a.m., the laboratory had performed no calibration verification for 16 chemistry analytes on the ACE Axcel analyzer since installation on 10-4-18. 3. The manufacturer's instructions require calibration verification when control materials are unacceptable, following specific maintenance procedures, and at a minimum every 6 months. 4. The laboratory reported approximately 101 patient results each month from 10-4-18 through 6-20-19. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on interview with the technical consultant on 6-20-19 at 11:00 a.m. and surveyor review of laboratory records from 11-29-17 through 6-20-19, the technical consultant documented monthly Quality Assessment review of records but failed to detect the lack of calibration verification and preventive maintenance (including documentation of room temperature) for the Alfa Wassermann chemistry analyzer as specified by the manufacturer. Findings include: 1. No documentation of room temperature as specified by the manufacturer since 11-29-17. (Refer to D5413). 2. No performance of preventive maintenance as specified by the manufacturer since installation of the Alfa Wassermann ACE Axcel chemistry analyzer on 10-4-18. -- 3 of 4 -- (Refer to D5429). 3. No performance of calibration verification as specified by the manufacturer for all analytes on the Alfa Wassermann chemistry analyzer. (Refer to D5439). 4. Failure to follow the manufacturer's reconstituted, open-vial stability procedure for the Alfa Wassermann chemistry controls. (Refer to D5415). -- 4 of 4 --