Upper Valley Pedi & Adolescent

Summary Statement of Deficiencies D0000 A recertification survey was conducted on July 12, 2018. The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493. 1403 laboratories performing moderate complexity testing; laboratory director 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 laboratory policy, review of the laboratory's American Proficiency Institute (API) proficiency testing records from 2017 and 2018, it was determined the laboratory had not successfully participated in a proficiency testing program approved 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 -- by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of hematology for the analyte White Blood Cell Differential. (refer to D2130) D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on laboratory policy, review of the laboratory's American Proficiency Institute (API) proficiency testing records from 2017 and 2018, and confirmed in interview, it was determined the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of hematology. The findings included: 1. A review of the laboratory's policy titled, "Proficiency Testing" approved by the laboratory director January 2018, stated, "Score of 80% or more for analytes in a subspecialty is consider [sp] successful performance." 2. A review of the laboratory's API proficiency testing records for 2017 and 2018 revealed the following: API 2017 - 3rd event the laboratory received an unsatisfactory score of 47% for WBC Differential API 2018 - 1st event laboratory failed to participate and received an unsatisfactory score of 0% for WBC Differential API 2018 - 1st event laboratory failed to participate and received an unsatisfactory score of 0% for RBC API 2018 - 1st event laboratory failed to participate and received an unsatisfactory score of 0% for HCT API 2018 - 1st event laboratory failed to participate and received an unsatisfactory score of 0% for HGB API 2018 - 1st event laboratory failed to participate and received an unsatisfactory score of 0% for Platelets 3. An interview with the technical consultant on July 12, 2018 at 10:00 hours in the break room confirmed the findings. He confirmed that the laboratory implemented a new analyzer in October 2018 and chose the wrong method code for the 3rd event of 2017 and failed to participate in the 1st event of 2018. Key: [sp] - spelling % - percent WBC - white blood cell RBC - red blood cell HCT - hematocrit HGB - hemoglobin D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on laboratory policy, review of the laboratory's American Proficiency Institute (API) proficiency testing records from 2017 and 2018, and confirmed in interview, it was determined the laboratory failed to attain an overall score of at least 80% in the subspecialty of hematology. The findings included: 1. API 2018-1st event lab received a score of 0% for hematology testing event. 2. An interview with the technical consultant on July 12, 2018 at 10:00 hours in the break room confirmed the findings. He confirmed that the laboratory chose the wrong method code for the 3rd event of 2017 and failed to participate in the 1st event of 2018. D2130 HEMATOLOGY CFR(s): 493.851(f) -- 2 of 5 -- 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 laboratory policy, review of the laboratory's American Proficiency Institute (API) proficiency testing records from 2017 and 2018, and confirmed in interview, it was determined the laboratory failed to achieve satisfactory performance (80 % or greater) for the same analyte in the specialty of hematology in two consecutive testing events or two out of three consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT (proficiency testing) performance. The findings included: 1. A review of the laboratory's policy titled, "Proficiency Testing" approved by the laboratory director January 2018, stated, "Score of 80% or more for analytes in a subspecialty is consider [sp] successful performance." 2. A review of the laboratory's API proficiency testing records for 2017 and 2018 revealed the following: API 2017 - 3rd event the laboratory received an unsatisfactory score of 47% for WBC Differential API 2018 - 1st event laboratory failed to participate and received an unsatisfactory score of 0% for WBC Differential. 3. An interview with the technical consultant on July 12, 2018 at 10:00 hours in the break room confirmed the findings. He confirmed that the laboratory chose the wrong method code for the 3rd event of 2017 and failed to participate in the 1st event of 2018. Key: [sp] - spelling % - percent WBC - white blood cell D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records from November 2016 to June 2018, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of reviewing quality over time for February 2017 and March 2017. The findings were: 1. On July 12, 2018, the laboratory was asked to provide quality control records for February and March 2017. The records provided were daily quality control printouts from the laboratory's previous hematology analyzer, the Cell Dyn 1800. 2. When testing personnel three (as listed on Form CMS-209) was asked if there were any other quality control records available for review for February 2017 and March 2017 that would provide documentation of evaluating quality control to detect errors over time, she replied, "No, these are the only records I could locate." 3. The above findings were confirmed in an interview with the technical consultant on July 12, 2018 at 11:20 hours in the break room. He revealed that the facility had a previous technical consultant and those records had not been located. -- 3 of 5 -- 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 review of the laboratory's American Proficiency Institute (API) proficiency testing records, review of laboratory policy, and confirmed in interview of facility personnel, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. (refer to D6016) D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on review of verification records for The Medonic M series hematology analyzer and confirmed in interview of facility personnel, the laboratory director failed to ensure verification procedures were accurate prior to patient testing. The findings were: 1. Review of the laboratory's verification records for the Medonic M series hematology analyzer revealed the instrument was installed in October 2017. 2. Further review of the verification records for the Medonic M series hematology analyzer revealed the laboratory performed and completed studies for accuracy, precision, reportable range and a normal patient range. However, the laboratory director failed to approve the studies. 3. An interview with the technical consultant on July 11, 2018 at 10:30 hours in the break room confirmed the findings. 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 review of the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in interview of facility personnel, it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services -- 4 of 5 -- provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. (refer to D2130) D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records, review of verification records for the Medonic M series hematology analyzer, and confirmed in interview of facility personnel, the laboratory director failed to ensure each testing person was trained prior to testing patients when a new hematology analyzer was implemented in October 2017. The findings were: 1. Review of the laboratory's verification records for the Medonic M series hematology analyzer revealed the instrument was installed and patient testing began in October 2017. 2. Review of the laboratory's personnel records for testing persons one, two, and three revealed no training records were available for review that would provide documentation of each testing being trained on the new analyzer prior to patient testing. 3. Review of the Medonic M series installation binder on July 12, 2018 under "Training" revealed no training records for each of the testing persons was available for review. 4. An interview with the technical consultant on July 12, 2018 at 10:30 hours in break room confirmed the findings. -- 5 of 5 --