Danbury Medical Group Llc

Summary Statement of Deficiencies D0000 A proficiency testing (PT) desk review of the Danbury Medical Group Laboratory was conducted pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. 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 proficiency testing (PT) record review, the laboratory failed to successfully perform in two consecutive testing events in the specialty of chemistry for the regulated analyte sodium (Na). Findings include: 1. Record review of the Center for Medicare & Medicaid Services (CMS) CASPER 0155D Report on 8/12/19 revealed the laboratory failed to obtain a score of at least 80% leading to unsatisfactory scores 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 -- for two consecutive PT events for analyte # 0475 'Na' as follows: Year/Event # Score 2019 Event 1 60% 2019 Event 2 60% 2. Record review of the American Association of Bioanalysts (AAB) PT results on 8/15/19 confirmed the above unsatisfactory scores. Refer to citation: D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 Proficiency Testing (PT) record review the laboratory failed to achieve successful performance for the same analyte in two consecutive PT events in the specialty of chemistry. Findings include: 1. Record review of the Center for Medicare & Medicaid Services (CMS) CASPER 0155D Report on 8/12/19 revealed the laboratory failed to obtain a score of at least 80% leading to unsatisfactory scores for two consecutive PT events for analyte # 0475 sodium (Na) as follows: Year/Event # PT Score 2019 Event 1 60% 2019 Event 2 60% 2. Record review of the American Association of Bioanalysts (AAB) PT results on 8/12/19 revealed the laboratory failed to obtain a score of at least 80% leading to unsatisfactory scores in two consecutive PT events as evidenced below. Year/Event # PT score 2019 - Event - 1 60% 2019 - Event - 2 60% 3. The above findings were confirmed by the laboratory manager in an electronic communication dated 8/13/19. 4. This is the first unsuccessful performance for the regulated analyte Na. 5. The laboratory performs 4,139 Na tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to investigate or take remedial action when unacceptable Proficiency Testing (PT) scores are received. Findings include: 1. Record review of the American Association of Bioanalysts (AAB) PT reports on 1/15/19 revealed unacceptable scores were obtained for the following events: a. 2017- Event 2 for iron and sodium. b. 2018- Event 1 for cholesterol, HDL and event 2 for iron. c. Investigation or remedial action was not documented for the above unacceptable results. 2. Staff interview with testing personnel #1 (TP#1) on 1/15/19 at 11:00 AM confirmed the laboratory did not investigate and take remedial action for the unacceptable PT results. TP#1 also stated they were unaware an investigation was required for PT scores less than 100%. 3. The laboratory performs 1,594 iron, 4,137 sodium and 3,193 cholesterol, HDL tests annually in the specialty of routine chemistry. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to investigate or take remedial action when unacceptable proficiency testing (PT) scores are received. Findings include: 1. Record review of the American Association of Bioanalysts (AAB) PT evaluation reports on 1/15/19 revealed the laboratory obtained unacceptable PT scores for the following events: a. 2017- Event 2 for platelets. b. 2018- Event 3 for hematology cell identification. c. Investigation or remedial action was not documented for the above unacceptable PT results. 2. Staff interview with testing personnel #1 (TP#1) on 1/15/19 at 11:00 AM confirmed the laboratory did not investigate or take remedial action for the unacceptable PT results. TP#1 also stated they were unaware an investigation was required for PT scores less than 100%. 3. The laboratory performs 74,080 tests annually in the specialty of hematology. 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 record review and staff interview the laboratory failed to document daily temperature function check of equipments in the specialty of chemistry and hematology. Findings include: 1. Record review of the temperature logs on 1/15/19 revealed: a. Temperatures were not being recorded daily in 2017 and 2018 for freezer with model #253.65812508. b. Temperature for "small refrigerator", "Nur fridge" and "Freezer" were not recorded daily in 2017 specifically on weekends and when testing personnel #1 (TP#1) was on vacation. c. Room temperature readings were not documented from February through May in 2017. d. In-use reagents, calibrators, quality control and patient specimens to be tested are currently stored in the above refrigerators and freezer. 2. Interview with TP #1 on 1/15/19 at 2:00 PM confirmed the above findings. 3. The laboratory performs approximately 152,212 moderately complexity tests annually. 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 5 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document maintenance(s) for laboratory equipment(s) to ensure accurate and reliable test results. Findings include: 1. Record review on 1/15/19 of the equipment(s) preventive maintenance (PM) log revealed annual PM of the Horiba ABX Micros 60 Hematology analyzer was not performed or documented after 2/27/17 as recommended by the manufacturer. 2. Staff interview with the testing personnel (TP) #1 on 1/15/19 at 11: 00 AM confirmed the above finding. 3. The laboratory performs 74,080 tests in the specialty of hematology annually. 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 on record review and staff interview, the laboratory failed to perform calibration of the hematology analyzer at the required frequency. Findings include: 1. Calibration record review on 1/15/19 revealed the following: a. Horiba ABX Micros 60 Hematology analyzer was calibrated on 3/23/16 when installed and then on 2/27/17 when preventive maintenance was performed. Documentation for calibration after 2/27 /17 was not available. b. Records of semi-annual calibration was not available for the period of March 2017 through 1/15/19 at the time of onsite inspection. 2. Staff interview with the testing personnel #1 (TP#1) on 1/15/19 at 11:30 AM confirmed the six months calibrations were not performed in a timely manner for the above indicated period. TP#1 stated he/she was unaware calibration was required every six months. 3. The laboratory performs 74,080 tests annually in the specialty of hematology. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if -- 3 of 5 -- applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to maintain both the original and corrected test result when corrections are made to patient final test reports. Findings include: 1. Record review of 2 of 2 corrected patient final test reports on 1/15/19 revealed the reports did not clearly indicate the original result that was previously reported. It was further revealed the original report was not available for review. 2. Record review of the laboratory procedure "Laboratory Policy" section for "Patient Reports" on 1/15/19 revealed: a. The laboratory must maintain copies of the original report as well as the corrected report. b. A log must be kept for result modifications which was unavailable. 3. Staff interview with testing personnel #1 on 1 /15/19 at 1:10 PM confirmed the original result was not indicated in the corrected report and a log for result modification is not available. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require