Compassionate Cancer Care

Summary Statement of Deficiencies D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory personnel competency documentations, and interview with the technical consultant (TC) and the laboratory staff, it was determined that the laboratory failed to retain documentations of personnel competency for at least 2 years. The findings included: b. There were no documentations of personnel competency available for 2021. c. The laboratory failed to retain the documentations of personnel competency for at least 2 years. b. The laboratory technical consultant and the laboratory staff affirmed (7/15/2022 @10:35 am) that there were no documentations of personnel competency available for 2021, see D-5209. 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 review of CMS 209 and the documentations of personnel competency records, and interview with the technical consultant (TC) and the laboratory staff, it was determined that the laboratory failed to follow written policies and procedures to assess personnel competency timely. The findings included: a. The laboratory failed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- to follow written policies and procedures to assess and retain documentations of personnel competency in 2001. b. Review of the current CMS 209, a "Laboratory Personnel Report (CLIA)", which indicates 10 testing personnel (TP). c. Review of the last CLIA CMS 209 (9/17/2021) , which had listed 3 TP. d. There were 8 new TP on the 2022 CMS 209 form, when compared with 2021 CMS 209 form in the 9/17 /2021 survey. d. The technical consultant affirmed (7/15/2022 @10:35 am) that there were no documentations of personnel competency available in 2021. 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 the laboratory's digital thermometer device (DT) and review of the temperature log, and interview with the technical consultant (TC) and the laboratory staff, it was determined that the laboratory failed to follow the manufacturer instructions to ensure and monitor the refrigerator temperature and maintain the quality of the laboratory's control materials and the patient samples in the refrigerator. The findings included: a . The laboratory staff failed to follow the manufacturer instructions for the use of a Fisher digital thermometer. b. The laboratory used a Fisher DT which features 1) Alarm (On/Off), 2) Current temperature, 3) Lo/Hi mode (setting for acceptable temperature range), 4) Min/Max mode (indicating the lowest or higher temperature ever reached in the past before reset), and 5) Reset. c. At the time (7/15/2022 @ 11:15 am) the DT indicated Alarm was at Off position. a current temperature of 6 oC, Min 4 oC and Max 14 oC, (no date or time provided by the DT for the Min 4 oC, Max 14 oC recorded) d. The Alarm went off when the laboratory staff turned the DT to "On" from "Off" position, which indicated that the temperature was once out of acceptable temperature range, sometime in the past. e. The laboratory staff pressed the mode to Lo/Hi, it showed "Lo" at 10 oC and "Hi" at 30 oC, which indicated that the laboratory had set the refrigerator's acceptable temperature range to this DT: 10 to 30 oC to monitor the condition of the refrigerator. f. The laboratory has established the acceptable temperature range between 4 to 10 oC to maintain the quality of the CBC control materials and/patient specimens in the refrigerator. g. The laboratory staff failed to ensure the temperatures of the refrigerator maintained within the acceptable temperature range, 4 to 10 oC consistently. 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. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory blood drawing station and checked various blood collection tubes in the tube racks, and interview with the laboratory staff, it was determined that the laboratory failed to ensure that the phlebotomist did not use outdated blood collection tubes for the patient blood drawing. The findings included: a. The laboratory failed to remove outdated blue top blood collection tubes which were expired on 6/30/2022. b. The laboratory kept outdated blue top tubes in the rack at the blood drawing station at the time of survey (7/15/2022 @ 10:45 AM). c. The laboratory failed to ensure the phlebotomist did not use outdated blood collecting tubes. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on observation of the blood drawing station, digital thermometer device (DT), review of the laboratory records, and interview with the technical consultant (TC) and the laboratory staff, it was determined that the laboratory failed to follow written policies and procedures (P&P) to maintain an ongoing quality assessment, and to ensure accuracy, reliability, and timely of the patient test results reports. The findings included: a. The laboratory failed to follow written policies and procedures, and maintain an ongoing mechanism to monitor, assess, and ensure accuracy, reliability and timely of the patient test result reports including: 1. documenting personnel competency and retaining of the documentations (see D-3039 and D-5209), 2. monitoring DT and constantly maintaining temperature within the acceptable temperature range (see D-5413), 3. removing outdated blood collection tubes (see D- 5417) 4. providing pertaining Expected values/reference intervals (see D-5807) D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's patient test result reports, and interview with the technical consultant (TC) and the laboratory staff, it was determined that the laboratory failed to provide pertinent "reference intervals or "normal" values as determined by the laboratory performing the tests. The findings included: a. The laboratory performs complete blood counts (CBC) testing using Celldyn Emerald to report WBC, WBC with automated cell differentials, RBC, Hemoglobin (Hgb), Hematocrit (Hct) and Platelet Count (Plt). b. The laboratory's patient CBC result reports provided Hgb and Hct the same pertinent "Expected values" (Reference intervals), respectively for Male and Female. c. The laboratory provided Hgb pertinent "Expected values" for Male, and Female between 12.0 and 18.0 g/dL. d. The -- 3 of 4 -- laboratory provided Hct pertinent "Expected values" for Male, and Female between 37.0 and 51.0 %. e. The technical consultant affirmed (7/15/2022 @11:50 am) that the Hgb and Hct pertinent "Expected values" are the same for both Male and Female. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on observation of the blood drawing station and digital temperature device (DT), review of the laboratory records and patient test result reports, and interview with the technical consultant (TC) and the laboratory staff, it was determined that the laboratory director failed to ensure that the quality control and quality assessment programs were maintained to identify failures in quality as they occur. The findings included: a. The laboratory director failed to follow and maintain an ongoing quality assessment for ensuring accuracy, reliability and timely of the patient test result reports and to provide quality laboratory operations (see D-5791). -- 4 of 4 --

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Hematology constituting unsuccessful PT performance. (See D2130) 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 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analytes, WBC Differential (WBC Diff), Red Blood Cell count (RBC), Hematocrit (HCT), Hemaglobin (HGB), White Blood Cell count (WBC), and Platelet count (PLT CT), resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analytes, WBC Diff, RBC, HCT, HGB, WBC, and PLT CT, as follows: 2021 Q1 2021 Q2 WBC Diff 13% 0% RBC 0% 0% HCT 20% 0% HGB 0% 0% WBC 20% 0% PLT CT 0% 0% Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analytes, WBC Diff, RBC, HCT, HGB, WBC, and PLT CT. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analytes, WBC Diff, RBC, HCT, HGB, WBC, and PLT CT, the laboratory repeatedly failed to achieve -- 2 of 3 -- satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performances. (see D2016 and D2130) -- 3 of 3 --