Pricare Pa

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 CMS (Centers for Medicare and Medicaid Services) CASPER report, API (American Proficiency Institute) proficiency testing (PT) evaluations, and an interview, the laboratory failed to successfully participate in PT for Calcium (Ca) and Thyroid Stimulating Hormone [TSH (Endocrinology)]. The laboratory failed these tests for two consecutive testing events, Event #3, 2022 and Event #1, 2023. The findings include: Refer to D2096. Refer to D2104. Refer to D2108. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in 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 review of CMS (Centers for Medicare and Medicaid Services) CASPER report, API (American Proficiency Institute) proficiency testing (PT) evaluations, and an interview with testing personnel, the laboratory failed to perform satisfactorily in Calcium (Ca) testing for two of three consecutive testing events, Event #3, 2022 and Event #1, 2023. The findings include: 1. A review of the CASPER report revealed the laboratory scored the following: a) Event #3, 2022 Calcium = 0 % (zero percent) b) Event #1, 2023 Calcium = 40 % 2. A review of the API PT evaluations confirmed the above noted scores. D2104 ENDOCRINOLOGY CFR(s): 493.843(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of CMS (Centers for Medicare and Medicaid Services) CASPER report, API (American Proficiency Institute) proficiency testing (PT) evaluations, and an interview with testing personnel, the laboratory failed to return the proficiency testing results to the PT program within the specified timeframe for grading. This untimely submission resulted in unsatisfactory performance in Calcium and TSH testing for Event #3, 2022. The findings include: 1. A review of the CMS CASPER report and the API PT evaluations revealed the laboratory scored the following: a) Event #3, 2022; Endocrinology (TSH) = 0 percent (%) b) Event #3, 2022; Routine Chemistry (Calcium) = 0 % 2. In an interview on 4/03/2023 at 2:17 PM, the testing personnel stated the zero percent scores for Event #3 were due to the failure to submit the results within the timeframe for grading. The laboratory submit the results one day following the deadline. D2108 ENDOCRINOLOGY CFR(s): 493.843(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 review of CMS (Centers for Medicare and Medicaid Services) CASPER report, API (American Proficiency Institute) proficiency testing (PT) evaluations, and an interview with testing personnel, the laboratory failed to perform satisfactorily in Endocrinology testing [Thyroid Stimulating Hormone (TSH)] for two consecutive testing events, Event #3, 2022 and Event #1, 2023. The findings include: 1. A review of the CMS CASPER report revealed the laboratory scored the following: a) Event #3, -- 2 of 3 -- 2022 Endocrinology (TSH) = 0 percent (%) b) Event #1, 2023 Endocrinology (TSH) = 60 % 2. A review of the API PT evaluations confirmed the above noted findings. 3. In an interview on 4/03/2023 at 2:17 PM, the testing personnel confirmed the two failures; and also stated the zero percent scores for Event #3 were due to the failure to submit the results within the timeframe for grading. The laboratory submit the results one day following the deadline. -- 3 of 3 --

Summary Statement of Deficiencies 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 a review of the Hematology calibration records, the policy and procedure manual, and an interview with the Technical Consultant, the laboratory failed to perform and document Emerald Cell Dyn Hematology calibrations with the required frequency specified by the laboratory policy. The laboratory failed to perform one of two calibrations due in 2021. The findings include: 1. A review of the Emerald Cell Dyn Hematology records revealed calibrations were performed on 3/5/2021 and ten months later on 1/28/2022. There was no documentation of a calibration performed the second half of 2021. 2. A review of the policy and procedure manual revealed the Quality Control/Calibration policy specified, "Hematology analyzers must be calibrated according to the following schedule: a. at least once every six months". 3. During the exit interview on August 8, 2022, at 1:40 PM, the Technical Consultant confirmed the above findings. . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) 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 -- 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 on a review of the Alfa Wasserman Ace Axcel Chemistry analyzer records and an interview with the Technical Consultant, the laboratory failed to perform one of four calibration verifications (C-V) for Cholesterol (Chol), Triglyceride (Trig), High- density lipoprotein (HDL), and Low-density lipoprotein (LDL) (four out of eighteen analytes) due in 2021 - 2022. The findings include: 1. A review of the records for the Alfa Wasserman Ace Axcel Chemistry analyzer revealed analytes on the instrument were calibrated with one calibrator. Analytes calibrated with less than three calibrators must have a C-V every six months as per CLIA requirements. 2. A review of Chemistry records revealed a C-V was performed using Audit Microcontrol linearity kits, as follows: A) 3/05/2021: all 18 Chemistry analytes B) 9/13/2021: all Chemistry analytes except Chol, HDL, Trig and LDL C) 3/16/2022: all 18 Chemistry analytes, and D) 7/25/2022: all 18 Chemistry analytes 3. During the exit interview on August 3, 2022, at 1:40 PM , the surveyor reviewed the Chemistry records with the Technical Consultant, who confirmed the laboratory had missed verifying the calibration for four analytes during the 9/13/2021 Alfa Wasserman Ace Axcel C-V. SURVEYOR ID #'s 32558 and 46291 Licensure and Certification Surveyors -- 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 a review of the API (American Proficiency Institute) proficiency testing records and an interview with the Technical Consultant (also Testing Personnel #1), the surveyor determined the laboratory failed to ensure proficiency testing was rotated among all laboratory testing personnel (four were listed on the personnel form #209), who perform moderate complexity testing on patient specimens. This affected 6 of 6 Hematology proficiency testing events reviewed by the surveyor. The findings include: 1. A review of the API proficiency testing records for 2016 and 2017, revealed Testing Personnel #1 (TP #1) performed all six of the Hematology testing events. 2. In an interview on 3/28/18 at 2:30 PM, TP #1 confirmed she performed all of the proficiency testing. TP #1 further confirmed other personnel were trained and qualified to perform Hematology testing and periodically performed testing on patient specimens. 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 a review of API (American Proficiency Institute) proficiency testing records and an interview with the Technical Consultant (also Testing Personnel #1), the 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 -- surveyor determined the laboratory failed to ensure all proficiency testing records for the survey review period, 3/2016 - 3/2018, were retained (must be retained for at least 2 years). This affected 3 of 6 testing events reviewed by the surveyor. The findings include: 1. A review of the API proficiency testing records revealed the following: a) the records failed to include the Hematology instrument printouts for Event #2, 2016. b) no attestation statement was included for core Chemistry Event #1, 2017. c) only the score sheets for the failing scores (creatinine, TSH (Thyroid Stimulating Hormone), PSA (Prostate Specific Antigen) and Free T4 (free - Thyroxine) were printed and retained for Chemistry Event #3 of 2016. 2. In an interview on 3/28/18 at 2:30 PM, the missing records and retention requirements were discussed with the Technical Consultant. 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 a review of the Policy and Procedure Manual (Employee Competency), a review of the laboratory personnel records, and an interview with the Technical Consultant (also Testing Personnel #1), the surveyor determined the laboratory failed to follow its policy and the CLIA regulations to ensure the competency of the Technical Consultant was assessed. The laboratory director did not ensure the Technical Consultant's competency was assessed semiannually, during the first year of employment, nor annually thereafter. This affected 1 of 1 technical consultants and 1 of 4 laboratory testing personnel. The findings include: 1. A review of the laboratory's policy and procedure manual, signed by the laboratory director, revealed a policy, titled "EMPLOYEE COMPETENCY," which included the following: "l. It is the laboratory director's responsibility to determine if and when an employee is competent to perform patient sample testing. ...3. ... New employees will have a documented competency assessment initially, at 6 months, one year and annually thereafter." 2. A review of the personnel records revealed Testing Personnel #1 (TP #1), who became the Technical Consultant in 2017, was initially trained in March of 2016. The record did not include a semi-annual competency assessment nor an annual assessment for this testing personnel. 3. In an interview on 3/28/18 at 2:30 PM, testing personnel stated the former technical consultant terminated employment in the middle of 2017 and she (TP #1) became the technical consultant. TP#1 also stated she had performed continuing education during the year; but confirmed her competency had not been assessed semiannually, during her first year of employment, nor annually since hired. 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, -- 2 of 3 -- 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 a review of the Policy and Procedure Manual, a review of the calibration records for the Hematology analyzer, Cell Dyn 1800, and an interview with the Technical Consultant (also Testing Personnel #1), the surveyor determined the laboratory failed to ensure calibrations for the analyzer were performed and documented, at least every six months, according to the laboratory's policies and procedures. The findings include: 1. A review of the laboratory policies revealed a calibration verification for the Cell Dyn 1800 should be performed at least every six months. 2. A review of the calibration records for the survey period, 3/2016 - 3/2018, revealed calibrations were performed on 6/02/16, 8/23/16, 3/24/17 and 3/21/18. Following the March of 2017 calibration, the laboratory should have calibrated the instrument (or verified the calibration) around the month of September. 3. In an interview on 3/28/18 at 2:30 PM, the Technical Consultant (also Testing Personnel #1) stated the calibrations are usually performed every six months. TP #1 also stated she thought she calibrated the Hematology analyzer in August of 2017, and she searched for the documentation. TP #1 did not provide documentation of a second calibration performed in 2017. Patricia Watson, BS, MT (ASCP) Licensure and Certification Supervisor -- 3 of 3 --