Cumberland Valley Rheumatology Pc

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 a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analyte Creatinine. Refer to D2096. 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 review of the CASPER 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in a proficiency testing for the analyte: Creatinine, which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 3rd event of 2021 and the 2nd event of 2022. Findings include: Analyte Year Event Score Creatinine 2021 3 20%. Creatinine 2022 2 0%. -- 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 interview with Testing personnel (TP) 1 and review of the competency assesment records , the laboratory failed to assess employee competency for 1of 1 Testing Personnel (TP) for each testing perform in hematology and chemistry from 2 /12/2020 to 05/03/2022. Findings include: 1. On the day of survey 05/03/2022 at 10: 11am, review of the competency records revealed, the laboratory did not perform separate competency assessment for hematology analyzer DXH 520 and chemistry analyzer ACE Axcel for 1 of 1 TP from 02/12/2020 to 05/03/2022. 2. Testing personnel 1 confirmed the findings above on 05/03/2022 at 12:25pm. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory procedures and interview with the Testing personnel 1, the laboratory failed to establish a validation procedure for new test/ analyzer from 02 /12/2020 to 05/03/2022. Findings include: 1. On the day of survey 05/03/2022 at 11: 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 -- 34am, the laboratory could not provide a procedure on how to validate a new analyzer. 2. The laboratory acquired a new hematology (DXH 520) analyzer in January 2020. 3. Interview with testing personnel 1 confirmed the above findings on 05/03/2022 at 12:26pm. 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 observation of the laboratory, temperature record review and interview with the Testing personnel (TP) 1, the laboratory failed to document room temperature for the storage of 4 of 4 chemistry reagents from 02/12/2020 to 05/03/2022. Findings include: 1. Observation of the laboratory on 05/03/2022 at 12:18pm, showed that the following chemistry reagents (ACE- Albumin, Total bilirubin, Bilirubin, Total protein) are stored in room temperature. 2. The laboratory failed to provide room temperature record. 3. Interview with testing personnel 1 confirmed the findings above on 05/03/2022 at 12:22pm. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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 observation of the laboratory and interview with Testing personnel 1, the laboratory failed to ensure 11 of 11 bottles of reagents did not have receive and opening dates in 05/03/2022 at 12:12pm. Findings Include: 1. Observation of the laboratory on 05/03/2022 at 12:12pm, revealed that the following reagents did not have receiving and opening dates: 2 of 2 bottle of ACE Albumin 2 of 2 bottle of ACE Total bilirubin 2 of 2 bottle of ACE Bilirubin 2 of 2 bottle of ACE Calcium 3 of 3 bottle of Total protein 2. Interview with testing personnel 1 confirmed the findings above on 05/03/2022 at 12:15 am. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the testing personnel (TP) #1, the laboratory failed to perform and document maintenance on the 2 of 2 thermometer for the storing of chemistry and hematology reagents from 02/12/2020 to 05/03/2022. Findings Include: 1. Based on observation of the lab on 05/03/2022 at 11: 25am, revealed that the following thermometers were expired on Nov 7, 2017. a. S/N 151885088- DXH 520 hematology reagent refrigerator. b. S/N 151885087- ACE Axcel chemistry reagent refrigerator. 2. Interview with TP #1 at 12:22pm confirmed the findings above. -- 3 of 3 --

Summary Statement of Deficiencies 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 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 upon chemistry instrument records and personnel interview with the Laboratory Supervisor on the date of the survey, the laboratory failed to perform and document calibration verification at least each 6 months, for 7 of 7 analytes run on the ACE AXEL Chemistry analyzer. Findings include: 1. At the time of the survey, the laboratory failed to provide documentation of calibration verification from (01/06 /2019 through 02/12/2020), for 7 of 7 analytes (albumin, creatinine, calcium, direct 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 -- bilirubin, total bilirubin, total protein, and uric acid) run on the ACE AXEL Chemistry analyzer. 2. .The last documented calibration verification for the 7 analytes run on the the ACE AXEL Chemistry analyzer, was performed on (01/05/2019). 3. During the survey (13:00 hours 02/12/2020), the Laboratory Supervisor confirmed the above findings. -- 2 of 2 --