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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 CMS CASPER reports (#153/#155), a review of API (American Proficiency Institute) proficiency testing performance evaluations, the surveyor determined the laboratory failed to successfully participate in proficiency testing for two consecutive testing events, Events #2 and #3 of 2019, for the White Blood Cell Differential (WBC differential). These consecutive failures resulted in an initial unsuccessful participation for the WBC differential. The findings include: 1. A review of the CASPER reports revealed the laboratory failed to successfully perform in WBC differential (Hematology testing) for Event #2 [score of 73 % (percent)] and Event #3 (score of 40 %) for 2019. 2. The API performance evaluations revealed 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 2 -- laboratory scored 73 % for the WBC differential for Event #2, 2019, and 40 % for the same testing for Event #3, 2019. 3. These two consecutive failures of the WBC differential resulted in an initial unsuccessful proficiency testing participation for the laboratory. 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 a review of the CMS CASPER reports (#153/#155), a review of API (American Proficiency Institute) proficiency testing performance evaluations, the surveyor determined the laboratory failed to satisfactorily perform in proficiency testing for the White Blood Cell Differential for two consecutive testing events, Events #2 and #3 of 2019. These two consecutive failures resulted in an initial unsuccessful participation for the WBC differential. The findings include: 1. Refer to D2016. -- 2 of 2 --

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 Casper reports (#153/#155), a review of API (American Proficiency Institute) proficiency testing performance evaluations, and a telephone interview with the Laboratory Manager (also a testing personnel), the surveyor determined the laboratory failed to successfully participate in proficiency testing for two consecutive testing events, Event #1 and #2 of 2018. The laboratory failed to participate in Event #2, 2018, resulting in a zero percent score. These failures resulted an an initial unsuccessful participation for the laboratory. The findings include: 1. A review of the Casper reports revealed the laboratory failed to successfully perform in RBC (Red Blood Cell Count, Hematology testing) for Events #1 and #2 of 2018. 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 -- laboratory scored 60 % for the RBC for Event #1, 2018 and 0 % for Event #2. 2. The API performance evaluations revealed the laboratory scored zero percent for Event #2, 2018, due to the laboratory's failure to participate in the testing event. The surveryor confirmed the 60 % RBC score for Event #1, 2018 with the API evaluations. 3. In a telephone interview at 1:20 PM on 9/20/18, the Laboratory Manager stated the failure to participate occurred because the new laboratory staff did not know to run the proficiency testing samples. The laboratory had an increased turn- over of testing personnel. The laboratory staff analyzed the samples after the API result submission date. The Laboratory Manager had recently become testing personnel and could not respond to the failure for Event #1, 2018. D2127 HEMATOLOGY CFR(s): 493.851(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 API (American Proficiency Institute) proficiency testing performance evaluations, and an interview with the Laboratory Manager, the surveyor determined the laboratory scored zero percent for the Red Blood Cell Count (RBC) for Event #2, 2018 (Failure to Participate), due to the laboratory's failure to return the results to API within the established time-frame for grading. This is unsatisfactory proficiency testing performance by the laboratory. The findings include: 1. A review of the API performance evaluations revealed the laboratory scored zero percent (0 %) for Event #2, 2018, due to the laboratory's failure to participate. 2. In a telephone interview on 9/20/18 at 1:20 PM, the Laboratory Manager stated the laboratory had new staff, who did not realize the proficiency testing samples needed to be analyzed. The samples were tested after the deadline of result submission, resulting in a zero percent score (Failure to Participate) by API. 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 a review of CMS Casper reports (#153/#155), a review of API (American Proficiency Institute) proficiency testing performance evaluations, and a telephone interview with the Laboratory Manager (also a testing personnel), the surveyor determined the laboratory failed to perform satisfactorily in proficiency testing for Red Blood Cell Count, Hematology testing (RBC) for two consecutive testing events, Event #1 and #2 of 2018. The laboratory failed to participate in Event #2, 2018, resulting in a zero percent score. These failures resulted an an initial unsuccessful proficiency testing participation for the laboratory. The findings include: 1. Refer to D2016. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) -- 2 of 3 -- 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of CMS Casper reports (#153/#155), a review of API (American Proficiency Institute) proficiency testing performance evaluations, and a telephone interview with the Laboratory Manager (also a testing personnel), the surveyor determined the Laboratory Director failed to ensure proficiency testing samples were tested, and the results returned to API within the established timeframe for grading for Event #2, 2018, Hematology testing. The failure to submit the results within the established time-frame resulted in zero percent scores (Failure to Participate). The findings include: 1. A review of the Casper report #155 for Event #2, 2018 revealed the laboratory scored zero percent (0 %) for Hematology testing. 2. A review of the API performance evaluations revealed the laboratory scored 0 % for Event #2, 2018, due to the laboratory's failure to participate. 3. In a telephone interview on 9/20/18 at 1:20 PM, the Laboratory Manager stated the laboratory had new staff, who did not realize the proficiency testing samples needed to be analyzed. The samples were tested after the deadline of result submission, resulting in a zero percent score (Failure to Participate) by API. Patricia Watson, BS, MT (ASCP) Licensure and Certification Supervisor -- 3 of 3 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observations, a review of the facility policies, and interviews with Testing Personnel (TP) #3 and #6, the laboratory failed to ensure Hematology specimens were labeled with two patient identifiers. Two of two patient samples observed were not labeled as per laboratory policy. The findings include: 1. During the initial laboratory tour with the Practice Manager on 5/23/2018 at 9:15 AM, the surveyor observed one purple-top tube with only a birth date in the rack next to the Hematology analyzer. A few minutes later the surveyor observed a second purple-top tube in the open sample holder on the analyzer. This sample had only a birth date hand-written on the label. The surveyor then asked TP #3 if the two samples were patient CBCs (Complete Blood Counts), and if they were properly labeled. TP #3 confirmed they were patient samples, and the labeling was not complete; then TP #3 looked in the Aprima electronic medical record system, and hand-wrote the patients' names on the two tubes. 2. As the entrance tour and interview continued at approximately 9:30 AM, TP #6 (the collector of the two CBC specimens) returned to the laboratory. The surveyor asked if he had properly labeled the two CBC samples he had drawn. TP #6 confirmed he had not, and stated he should label all samples with the patient's name, date of birth (DOB) and the date. 3. A review of the laboratory's policy entitled "VENIPUNCTURE AND SPECIMEN IDENTIFICATION POLICY", revealed under "Specimen Identification / Labeling Specimens must be labeled properly to ensure proper results. Each specimen label should include the following information: 1. The date specimen was collected 2. Patient name (Last, First) 3. Specimen ID (DOB)..." 4. 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 -- During the exit summation on 5/23/2018 at 3:45 PM, this concern was discussed and confirmed with the Practice Manager and TP #1. . D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of the 2017 Beckman Coulter AcT diff Hematology analyzer calibration records and an interview with the Practice Manager, the laboratory failed to ensure the November 2017 calibrator was used before its expiration date. This was observed on one of two 2017 calibrations reviewed. The findings include: 1. A review of records for the AcT diff Hematology analyzer, revealed a calibration was performed on 5/02/2017, and on 11/30/2017, using S-CAL Calibrator lot number 4728 with an expiry date of 11/11/2017. A note on the 11/30/2017 calibration records indicated the Laboratory Director had discovered the use of the expired calibrator, and had counseled the testing personnel. [This notation was not dated.] 2. During an interview on 5/23/2018 at 12:05 PM, the surveyor asked the Practice Manager when Laboratory Director had discovered this problem. After sending a text message to the Director, the Manager answered, "Yesterday" (5/22/2018). When asked if another valid calibration had been performed since the 5/02/2017 calibration, the Practice Manager answered no, stating they had not ordered a new calibrator until this week. Thus, the above noted findings were confirmed. SURVEYOR:Laura T. Williams, BS, MT (ASCP)Licensure and Certification Surveyor -- 2 of 2 --