Sayre Community Hospital

Summary Statement of Deficiencies D0000 The survey was performed on 07/30/18-08/02/18. Immediate Jeopardy was determined during the survey due to issues identified with Erythrocyte Sedimentation Rate (ESR) testing, using the Diesse Mini-Cube test system, that was not approved by the FDA. The laboratory voluntarily ceased patient testing, which abated the Immediate Jeopardy situation. The findings were reviewed with the chief executive officer, chief operating officer, chief clinical officer, clinical laboratory operations officer, and laboratory supervisor during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1215; D5024: Hematology 493.1250; D5400: Analytic Systems 493.1403; D6000: Laboratory Director, Moderate Complexity Testing 493.1409; D6033: Technical Consultant 493.1441; D6076: Laboratory Director, High Complexity Testing NOTE: The laboratory discontinued Blood Bank testing on 06/01/18, therefore, changing the status to a moderate complexity laboratory. The laboratory changed the laboratory director effective 07/23/18 to an individual qualifying as a moderate complexity laboratory director under 493.1405 (b) (5). D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 33 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the clinical laboratory operations officer and laboratory supervisor, the laboratory director failed to sign proficiency testing attestation statements. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records and identified attestation statements had either not been signed by the laboratory director, or signed by persons who did not qualify as a technical consultant (if delegated in writing for moderate complexity testing) or technical supervisor (if delegated in writing for high complexity Immunohematology testing) ; (2) The following was identified for 9 of 13 events reviewed: (a) Second 2017 Immunohematology Event - The attestation form had been signed by the previous laboratory supervisor (this person had earned an Associate Degree in Science, and therefore, did not qualify as a Technical Supervisor for Blood Bank or Laboratory Director for high complexity testing - this person had terminated employment in December 2017); (b) Second 2017 Chemistry Miscellaneous Event - The attestation form had been signed by the previous laboratory supervisor (this person did not qualify as a Technical Consultant or a Laboratory Director for moderate complexity testing); (c) Third 2017 Immunohematology Event - The attestation form had not been signed by the laboratory director (a pathologist was the laboratory director and technical supervisor for blood bank during this event); (d) Third 2017 Chemistry Core Event - The attestation form had been signed by the previous laboratory supervisor; (e) Third 2017 Microbiology Event - The attestation form had been signed by the previous laboratory supervisor; (f) Third 2017 Hematology/Coagulation - The attestation form had been signed by the previous laboratory supervisor; (g) First 2018 Immunohematology Event - The attestation form had been signed by the current laboratory director /technical consultant (this person had earned a Bachelor of Science degree, and therefore, did not qualify as a Technical Supervisor for Immunohematology or Laboratory Director for high complexity testing); (h) First 2018 Chemistry Core Event - The attestation form had not been signed by the laboratory director; (i) First 2018 Microbiology Event - The attestation form had not been signed by the laboratory director. (4) The surveyor explained to the clinical laboratory operations officer and laboratory supervisor that proficiency testing attestation statements for moderate complexity testing must be signed by the laboratory director or technical consultant (if delegated) and for Immunohematology testing must be signed by the laboratory director or technical supervisor (if delegated). NOTE: The Interpretive Guidelines under D2015 state "For moderate complexity testing, in accordance with 493.1407(e) (4)(i), the director may delegate the responsibility for signing the attestation statement to a technical consultant meeting the qualifications of 493.1409. For high complexity testing, in accordance with 493.1445(e)(4)(i), the director may delegate the responsibility for signing the attestation statement to a technical supervisor meeting the qualifications of 493.1447." D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, manufacturer's instructions, procedure manual, FDA -- 2 of 33 -- database, information provided by the distributing manufacturer, correspondence with the CMS Central Office FDA liaison, and interview with the clinical laboratory operations officer and laboratory supervisor, the laboratory failed to ensure the requirements were met for the specialty of Hematology. Findings include: (1) The laboratory failed to follow the manufacturer's instructions for implementing the Sysmex CA-620 analyzer. Refer to D5411; (2) The laboratory failed to demonstrate the performance specifications for the Alere Triage Meter Pro and the Sysmex XS 1000i; and failed to ensure the verified reportable ranges were used by the laboratory for the Sysmex CA-620. Refer to D5421; (3) The laboratory failed to establish the performance specifications of precision, reportable range, analytical sensitivity, analytical specificity, and reference intervals for an Erythrocyte Sedimentation Rate test system not cleared or approved by the FDA. Refer to D5423; (4) The laboratory failed to follow the manufacturer's quality control specifications for ESR (Erythrocyte Sedimentation Rate) testing. Refer to D5479; (5) The laboratory failed to perform two levels of quality control testing each eight hours of D-dimer testing. Refer to D5545; (6) The laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791; (7) The laboratory failed to make appropriate reference ranges available for coagulation testing. Refer to D5807. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the clinical laboratory operations officer and laboratory supervisor, the the laboratory failed to evaluate the accuracy of testing when a proficiency result had not been graded by the proficiency program. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. The review verified the laboratory did not address a result that was not graded by the proficiency testing program for 1 of 2 Chemistry Miscellaneous events as follows: (a) First 2018 Event (i) UDS Opiates - 1 of 3 results (Sample UDS-02) had not been evaluated by the proficiency testing program. Under "Expected Result" it stated, "See Data Summary." There was no evidence the laboratory reviewed the data summary to evaluate their results. (2) The surveyor reviewed the records with the clinical laboratory operations officer and laboratory supervisor. Both stated the laboratory had not evaluated the result that was not graded by the proficiency testing program. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. -- 3 of 33 -- This CONDITION is not met as evidenced by: Based on a review of records, procedure manual, manufacturer's instructions, procedure manual, and interview with the clinical laboratory operations officer and laboratory supervisor, the laboratory failed to monitor and evaluate the overall quality of analytic systems. Findings include: (1) The laboratory failed to follow the manufacturer's instructions for Urine Microscopic testing. Refer to D5411; (2) The laboratory failed to demonstrate the performance specifications for the Clostridium difficile test kit and the Clinitek Advantus analyzer; and failed to ensure the verified reportable ranges were used by the laboratory for the EPOC test system and Siemens Dimension analyzer. Refer to D5421; (3) The laboratory failed to perform maintenance procedures as required by the manufacturer. Refer to D5429; (4) The laboratory failed to perform two levels of quality control testing each day of patient testing. Refer to D5447; (5) The laboratory failed to perform a negative and positive control each day of patient testing. Refer to D5449; (6) The laboratory failed to perform one sample of control material each 8 hours of patient blood gas testing using a combination of control materials that include both low and high values on each day of testing. Refer to D5537; (7) The laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, procedure manual, and interview with the clinical laboratory operations officer and laboratory supervisor, the laboratory failed to follow the manufacturer's instructions. Findings include: SYSMEX CA-620 ANALYZER (1) On the second day of the survey, the clinical laboratory operations officer and laboratory supervisor stated to the surveyor the Sysmex CA-620 analyzer was put into use to perform PT/INR (Prothrombin Time /International Normalized Ratio) and PTT ((Partial Thromboplastin Time) testing on 07/10/17; (2) The surveyor reviewed the manufacturer's instructions for establishing a normal reference interval (the manufacturer required the establishment of a reference interval with a new analyzer). The manufacturer referred the reader to CLSI C28-A3c for information about establishing a reference interval which stated, "As indicated in this document, the working group endorses its previous recommendation that the best means to establish a reference interval is to collect samples from a sufficient number of qualified reference individuals to yield a minimum of 120 samples for analysis, by nonparametric means, for each partition (eg, sex, age range)." In addition, the manufacturer required the following for establishing a normal reference interval: (a) "Donors must be from a healthy population (no known pathological conditions)"; (b) "Donors should not take any medications, including aspirin"; (c) "Donors with a reasonably even distribution of males and females should be included"; (d) "Donors should span the adult age range. (NOTE: A separate range should be established for pediatric populations)"; (e) "Calculate mean and 2 SD range"; (f) "MNPT for INR calculation must be the geometric mean". (3) The surveyor reviewed the -- 4 of 33 -- implementation records for the analyzer. The following was identified for PT and PTT: (a) The lot numbers that were in use when the analyzer was implemented (and currently in use) were: (i) PT Reagent - Siemens Dade Innovin lot #539397 (ii) PTT Reagent - Siemens Actin FSL lot #556902 (b) The normal reference intervals had been established for PT and PTT as follows: (i) 21 donors had been utilized for PT and 22 donors had been utilized for PTT (instead of the 120 donors as required for establishment studies for a new analyzer); (ii) There was no documentation of the health status, medication history, age, and gender of the donors. (4) The surveyor reviewed the records with the clinical laboratory operations officer who stated the following: (a) The laboratory did not perform the 120 sample study; (b) There was no documentation to prove the health status, medication history, age, and gender of the donors. (5) The following were examples of patient testing performed when the normal reference intervals had not been established for the new analyzer as required: (a) Patient #123 - PT/INR testing performed on 07/10/17 and 07/13/17 (b) Patient #124 - PT/INR testing performed on 07/18/17 (c) Patient #125 - PT/INR and PTT testing performed on 07/23/17 (d) Patient #126 - PT/INR and PTT testing performed on 07/31/17 (e) Patient #127 - PT/INR and PTT testing performed on 08/06/17 (f) Patient #128 - PT/INR testing performed on 08/10/17 (g) Patient #129 - PT/INR and PTT testing performed on 08/18/17 (h) Patient #130 - PT/INR and PTT testing performed on 08/26/17 (i) Patient #131 - PT/INR testing performed on 09/03/07 (j) Patient #132 - PT/INR and PTT testing performed on 09/10/17 (k) Patient #133 - PT /INR and PTT testing performed on 09/20/17 (l) Patient #134 - PT/INR testing performed on 09/27/17 (m) Patient #135 - PT/INR testing performed on 10/09/17 (n) Patient #136 - PT/INR testing performed on 10/12/17 (o) Patient #137 - PT/INR and PTT testing performed on 10/28/17 (p) Patient #138 - PT/INR testing performed on 11 /09/17 (q) Patient #139 - PT/INR testing performed on 11/13/17 (r) Patient #140 - PT /INR and PTT testing performed on 11/28/17 (s) Patient #141 - PT/INR and PTT testing performed on 12/04/17 (t) Patient #142 - PT/INR testing performed on 12/19 /17 (u) Patient #143 - PT/INR testing performed on 12/31/17 (v) Patient #144 - PT /INR testing performed on 01/07/18 (w) Patient #145 - PT/INR and PTT testing performed on 01/18/18 (x) Patient #146 - PT/INR testing performed on 01/25/18 (y) Patient #147 - PT/INR and PTT testing performed on 02/07/18 (z) Patient #148 - PT /INR testing performed on 02/12/18 (aa) Patient #149 - PT/INR and PTT testing performed on 02/21/18 (bb) Patient #150 - PT/INR testing performed on 03/04/18 (bb) Patient #115 - PT/INR and PTT testing performed on 03/12/18 (cc) Patient #151 - PT/INR testing performed on 03/19/18 (dd) Patient #152 - PT/INR and PTT testing performed on 03/28/18 (ee) Patient # 153 - PT/INR and PTT testing performed on 04 /06/18 (ff) Patient #154 - PT/INR and PTT testing performed on 04/15/18 (gg) Patient #155 - PT/INR testing performed on 04/30/18 (hh) Patient #156 - PT/INR testing performed on 04/10/18 (ii) Patient #157 - PT/INR and PTT testing performed on 05/19 /18 (jj) Patient #158 - PT/INR testing performed on 05/30/18 (kk) Patient #159 - PT /INR testing performed on 06/05/18 (ll) Patient #160 - PT/INR testing performed on 06/13/18 and 06/28/18 (mm) Patient #161 - PT/INR testing performed on 06/20/18 (nn) Patient #162 - PT/INR testing performed on 06/29/18 (oo) Patient #163 - PT/INR testing performed on 07/05/18 (pp) Patient #164 - PT/INR performed on 07/13/18 (qq) Patient #165 - PT/INR testing performed on 07/20/18 (rr) Patient #166 - PT/INR testing performed on 07/24/18 (ss) Patient #167 - PT/INR and PTT testing performed on 07/31/18 URINE MICROSCOPIC (1) On the first day of the survey, the clinical laboratory operations officer and laboratory supervisor stated to the surveyor urine microscopic testing was performed in the laboratory; (2) On the third day of the survey, the laboratory supervisor stated to the surveyor, the KOVA system was used for performing urine microscopics (which consisted of KOVA tubes to centrifuge the urine specimen, the KOVA slide which was a plastic slide with 10 separate chambers, -- 5 of 33 -- and the KOVA Petter which was used to drop the specimen into a chamber on the KOVA slide. The laboratory began using this system to perform patient testing on 07 /10/17; (3) The surveyor reviewed the procedure titled, "Urinalysis Policy And Procedure" which stated, "Using the previously prepared centrifuge tube, place it in the urinalysis centrifuge and centrifuge for 4-7 minutes at 2500 rpm" (4) The surveyor then reviewed the manufacturer's instructions for the KOVA system and identified the laboratory was not following the instructions for centrifuging urine specimens. The instructions stated, "Centrifuge the KOVA tubes (each containing 12 ml of urine specimen) at a relative centrifugal force (rcf) of 400 for five minutes; approximately 1500 revolutions per minute (rpm) with a 6 inch radius rotor"; (5) The surveyor reviewed the findings with the laboratory supervisor, who stated the laboratory had routinely centrifuged the urine specimens at a speed of 2500 rpm and was not aware the manufacturer of the KOVA system required the urine specimens to be centrifuged at a speed of 1500 rpm; (6) The following were examples of patient urine microscopic testing performed: (a) Patient #170 - testing performed on 07/10/17 (b) Patient #171 - testing performed on 07/30/17 (c) Patient #172 - testing performed on 08/03/17 (d) Patient #173 - testing performed on 08/29/17 (e) Patient #174 - testing performed on 09/13/17 (f) Patient #175 - testing performed on 09/30/17 (g) Patient #176 - testing performed on 10/15/17 (h) Patient #177 - testing performed on 10/29/17 (i) Patient #178 - testing performed on 11/09/17 (j) Patient #179 - testing performed on 11/28/17 (k) Patient #180 - testing performed on 12/07/17 (l) Patient #181 - testing performed on 01/04/18 (m) Patient #182 - testing performed on 01/25/18 (n) Patient #183 - testing performed on 02/25/18 (o) Patient #184 - testing performed on 03/20/18 (p) Patient #185 - testing performed on 04/25/18 (q) Patient #186 - testing performed on 05/21/18 (r) Patient #187 - testing performed on 06/18/18 (s) Patient #188- testing performed on 07/16/18 (t) Patient #189 - testing performed on 08/01/18 D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records, procedure manual, and interview with the clinical laboratory operations officer and laboratory supervisor, the laboratory failed to demonstrate the performance specifications for new test methods; and failed to ensure the verified reportable ranges were used by the laboratory. Findings include: ALERE TRIAGE METER PRO (1) On the first day of the survey, the clinical laboratory operations officer and laboratory supervisor stated to the surveyor D-dimer testing was performed on the Alere Triage Meter Pro analyzer; (2) On the second day of the survey, the laboratory supervisor stated to the surveyor the laboratory began performing patient testing on 07/13/17 (the laboratory supervisor did not begin employment until 06/11/18); (3) The surveyor reviewed the validation records for the analyzer with the following identified: (a) There was no evidence the precision and reportable range had been demonstrated; (b) There was no evidence the reference range (normal range) had been verified. (4) The surveyor then reviewed the validation -- 6 of 33 -- records with the clinical laboratory operations officer and laboratory supervisor. Both stated they could not locate records to prove the precision and reportable range had been demonstrated and the reference range had been verified; (5) Refer to D5545 for examples of patient testing performed. SYSMEX CA-620 (1) On the second day of the survey, the clinical laboratory operations officer and laboratory supervisor stated the Sysmex CA-620 analyzer was put into use to perform PT (Prothrombin Time) and PTT ((Partial Thromboplastin Time) testing on 07/10/17; (2) The surveyor reviewed validation records for the analyzer and identified the reportable ranges had been verified by the laboratory as follows: (a) PT - 9.3-49.0 (b) PTT - 22.9-57.5 (3) The surveyor then requested documentation to verify the reportable ranges that were currently in use. The clinical laboratory operations officer provided the surveyor with a printout from the LIS (Laboratory Information System) which verified the laboratory was using reportable ranges that were wider than the verified ranges: (a) PT - -9999999.9999-66.0 (v) PTT - -9999999.9999-90.0 (4) The surveyor reviewed the findings with the clinical laboratory operations officer and laboratory supervisor. Both stated the laboratory was not using the reportable ranges that had been verified by the laboratory; (5) Refer to D5411 for examples of PT and PTT testing performed when the laboratory was not using the verified reportable ranges. SYSMEX XS-1000i (1) On the first day of the survey, the clinical laboratory operations officer and laboratory supervisor stated to the surveyor the Sysmex XS-1000i analyzer was used to perform patient CBC Complete Blood Count) testing (consisted of the analytes WBC (White Blood Cell), RBC (Red Blood Cell), Hemoglobin, Hematocrit, Platelet, MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Hemoglobin), and MCHC (Mean Corpuscular Hemoglobin Concentration) and automated 5 part differential (% and absolute Neutrophil, Lymphocyte, Eosinophil, and Basophil)); (2) On the third day of the survey, the laboratory supervisor stated to the surveyor the laboratory began patient testing on 07/10/17; (3) The surveyor reviewed the validation records for the analyzer with the following identified: (a) There was no evidence the precision and reportable ranges had been demonstrated for each analyte; (b) There was no evidence the reference ranges (normal range) had been verified for each analyte. (4) The surveyor then reviewed the validation records with the clinical laboratory operations officer and laboratory supervisor. Both stated they could not locate records to prove the precision and reportable ranges had been demonstrated and the reference ranges had been verified; (5) The following were examples of patient CBC testing performed: (a) Patient #272 - testing performed on 07/18/17 (b) Patient #273 - testing performed on 07/25/17 (c) Patient #274 - testing performed on 08/03/17 (d) Patient #275 - testing performed on 08/18/17 (e) Patient #276 - testing performed on 09/02/17 (f) Patient #277 - testing performed on 09/29/17 (g) Patient #278 - testing performed on 10/10/17 (h) Patient #279 - testing performed on 10/28/17 (i) Patient #280 - testing performed on 11/16/17 (j) Patient #281 - testing performed on 12/06/17 (k) Patient #282 - testing performed on 12/31/17 (l) Patient #283 - testing performed on 01/12/18 (m) Patient #284 - testing performed on 01/27/18 (n) Patient #285 - testing performed on 02/21/18 (o) Patient #286 - testing performed on 03/07/18 (p) Patient #287 - testing performed on 04/04/18 (q) Patient #288 - testing performed on 04/17/18 (r) Patient #289 - testing performed on 05/07/18 (s) Patient #290 - testing performed on 05/21/18 (t) Patient #291 - testing performed on 06/05/18 (u) Patient #292 - testing performed on 07/02/18 (v) Patient #293 - testing performed on 07/30/18 EPOC (1) On the first day of the survey, the clinical laboratory operations officer and laboratory supervisor stated to the surveyor Blood Gas (pH, pCO2, and PO2) and Lactic Acid testing were performed using the EPOC test system; (2) On the second day of the survey, the laboratory supervisor stated to the surveyor the laboratory began performing patient testing on 07/10/17; (3) The surveyor reviewed the validation records for the analyzer and identified there was no evidence the reference -- 7 of 33 -- ranges had been verified; (4) In addition, the surveyor reviewed the validation records and the EPOC procedure manual and identified the reportable ranges that had been demonstrated by the laboratory did not match the reportable ranges listed in the procedure manual: (a) The laboratory had demonstrated the following reportable ranges: (i) pH - 6.663-7.863 (ii) pO2 - 29.5-618.0 (iii) pCO2 - 16.3-131.4 (iv) Lactic Acid - 0.48-17.60 (b) The procedure manual listed the reportable ranges as follows: (i) pH - 6.5-8.0 (ii) pO2 - 27.0-680 (iii) pCO2 - 15-145 (iv) Lactic Acid - 0.4-19.4 (5) Upon further review of the validation records, the surveyor identified the validation had not been completed and signed off by the laboratory before the laboratory began patient testing on 07/10/17. The validation had been performed from 07/09/17 through 07/19/17, and the records had been signed off as approved by the laboratory on 07/20 /17; (6) The surveyor reviewed the records with the clinical laboratory operations officer and laboratory supervisor. Both stated the following: (a) The reference ranges had not been verified; (b) The procedure manual did not reflect the reportable ranges that had been demonstrated by the laboratory. It appeared the laboratory had used the manufacturer's reportable ranges instead of the ranges that had been demonstrated; (c) The validation had not been completed before the laboratory began patient testing. (7) The following were examples of patient testing performed: (a) Patient #86 - Blood Gas testing performed on 07/10/17 (b) Patient #87 - Blood Gas testing performed on 07/12/17 and 07/14/17 (c) Patient #88 - Blood Gas testing performed on 07/13/17 (d) Patient #89 - Lactic Acid testing performed on 07/15/17 (e) Patient #90 - Blood Gas testing performed on 07/16/17 (f) Patient #91 - Blood Gas testing performed on 07/17 /17 (g) Patient #92 - Lactic Acid testing performed on 07/18/17 and Blood Gas testing performed on 08/24/17 (h) Patient #93 - Lactic Acid testing performed on 07/20/17 and 06/03/18 (i) Patient #94 - Blood Gas testing performed on 08/01/17 (j) Patient #95 - Lactic Acid testing performed on 08/07/17 (k) Patient #96 - Lactic Acid testing performed on 08/19/17 (l) Patient #97 - Lactic Acid testing performed on 12/02/17 (m) Patient #98 - Blood Gas testing performed on 12/24/17 and 12/28/17 (n) Patient #99 - Lactic Acid testing performed on 12/29/17 (o) Patient #100 - Lactic Acid testing performed on 02/07/18 (p) Patient #101 - Blood Gas and Lactic Acid testing performed on 02/10/18 (q) Patient #102 - Blood Gas testing performed on 02/21/18 (r) Patient #103 - Blood Gas testing performed on 02/27/18 (s) Patient #104 - Lactic Acid testing performed on 04/07/18 (t) Patient #105 - Lactic Acid testing performed on 04 /17/18 and 07/06/18 (u) Patient #106 - Blood Gas testing performed on 04/21/18 and 04/22/18 (v) Patient #107 - Lactic Acid testing performed on 04/25/18 (w) Patient #108 - Blood Gas testing performed on 04/29/18 (x) Patient #109 - Lactic Acid testing performed on 04/26/18 (y) Patient #110 - Blood Gas testing performed on 06/05/18 (z) Patient #111 - Lactic Acid testing performed on 06/06/18 and Blood Gas testing performed on 07/24/18 (aa) Patient #112 - Lactic Acid testing performed on 06/10/18 (bb) Patient #113 - Lactic Acid testing performed on 06/21/18 (cc) Patient #114 - Blood Gas testing performed on 06/24/18 (dd) Patient #115 - Lactic Acid testing performed on 06/25/18 (ee) Patient #116 - Lactic Acid testing performed 06/29/18 (ff) Patient #117 - Lactic Acid testing performed 07/04/18 (gg) Patient #118 - Lactic Acid testing performed on 07/18/18 (hh) Patient #119 - Lactic Acid testing performed on 07 /22/18 (ii) Patient #120 - Blood Gas testing performed 07/26/18 CLOSTRIDIUM DIFFICILE (1) On the first day of the survey, the clinical laboratory operations officer and laboratory supervisor stated to the surveyor Clostridium difficile (C. diff) testing was performed using the Alere Techlab C. diff QuikChek Complete test kit; (2) On the second day of the survey, the laboratory supervisor stated to the surveyor the laboratory began patient testing on 07/10/17; (3) The surveyor then reviewed records and could not locate documentation to substantiate the performance specifications (i.e., accuracy, precision) had been demonstrated for the test kit before it had been put into use; (4) The surveyor asked the clinical laboratory operations -- 8 of 33 -- officer and laboratory supervisor if the performance specifications had been demonstrated for the test kit. Both stated the performance specifications had not been demonstrated for the test kit; (5) The following were examples of patient C. diff testing performed: (a) Patient #22 - testing performed on 07/26/17 (b) Patient #23 - testing performed on 01/02/18 (c) Patient #24 - testing performed on 01/21/18 (d) Patient #25 - testing performed on 01/30/18 (e) Patient #26 - testing performed on 01 /31/18 and 04/03/18 (f) Patient 327 - testing performed on 02/22/18 (g) Patient #28 - testing performed on 03/20/18 (h) Patient #29 - testing performed on 03/26/18 (i) Patient #30 - testing performed on 03/27/18 (j) Patient #31 - testing performed on 04 /17/18 (k) Patient #32 - testing performed on 05/16/18 (l) Patient #33 - testing performed on 05/17/18 (m) Patient #34 - testing performed on 06/29/18 (n) Patient #122 - testing performed on 07/15/18 CLINITEK ADVANTUS (1) On the first day of the survey, the clinical laboratory operations officer and laboratory supervisor stated to the surveyor the Siemens Clinitek Advantus analyzer was used Urinalysis testing (for the analysis of Leukocytes, Nitrites, Protein, Blood, Glucose, Ketones, Bilirubin, Urobilinogen, pH, Specific Gravity, and Creatinine in patient urine specimens); (2) On the third day of the survey, the laboratory supervisor stated to the surveyor the laboratory began patient testing on 07/10/17; (3) The surveyor reviewed the validation records for the analyzer with the following identified: (a) There was no evidence the precision and reportable ranges, as applicable, had been demonstrated for each constituent; (b) There was no evidence the reference ranges (normal range) had been verified for each constituent. (4) The surveyor then reviewed the validation records with the clinical laboratory operations officer and laboratory supervisor. Both stated they could not locate records to prove the precision and reportable ranges had been demonstrated and the reference ranges had been verified; (5) The following were examples of patient Urinalysis testing performed: (a) Patient #190 - testing performed on 07/11/17 (b) Patient #191 - testing performed on 07/23/17 (c) Patient #192 - testing performed on 08/07/17 (d) Patient #193 - testing performed on 08/28/17 (e) Patient #194 - testing performed on 09/10/17 (f) Patient #195 - testing performed on 09/26/17 (g) Patient #196 - testing performed on 10/16/17 (h) Patient #197 - testing performed on 11/09/17 (i) Patient #198 - testing performed on 11/26/17 (j) Patient #199 - testing performed on 12/03/17 (k) Patient #200 - testing performed on 12/29/17 (l) Patient #201 - testing performed on 01/03/18 (m) Patient #202 - testing performed on 01/25 /18 (n) Patient #203 - testing performed on 02/10/18 (o) Patient #204 - testing performed on 03/13/18 (p) Patient #205 - testing performed on 04/01/18 (q) Patient #206 - testing performed on 04/20/18 (r) Patient #207 - testing performed on 05/21/18 (s) Patient #208 - testing performed on 06/21/18 (t) Patient #209 - testing performed on 07/07/18 (u) Patient #210 - testing performed on 07/19/18 (v) Patient #211 - testing performed on 08/01/18 SIEMENS DIMENSION EXL 200 (1) On the first day of the survey, the clinical laboratory operations officer and laboratory supervisor stated to the surveyor the Siemens Dimension EXL 200 analyzer was used to perform patient CMP* (Comprehensive Metabolic Panel) testing; (2) On the third day of the survey, the laboratory supervisor stated to the surveyor the laboratory began patient testing on 07/10/17; (3) The surveyor reviewed validation records for the analyzer and identified the reportable ranges had been verified by the laboratory as follows: (a) BUN (Blood Urea Nitrogen) - 5.97-44.51 (b) Calcium - 5.35-13.24 (c) Creatinine - 0.594-5.115 (d) Glucose - 51.8-235.7 (e) Chloride - 86.0-122.0 (f) CO2 - 18.71-35.88 (g) Potassium - 2.7-7.4 (h) Sodium - 117.0-159.0 (i) Albumin - 2.58-4.48 (j) ALT (Alanine Aminotransferase) - 19.0-261.0 (k) AST (Aspartate Aminotransferase) - 20.2-344.03 (l) Alkaline Phosphatase - 58.0-246.0 (m) Total Bilirubin - 0-4.2 (n) Total Protein - 4.57-10.25 (4) The surveyor then requested a printout from the analyzer to verify the reportable ranges that had been programmed into the analyzer and were currently in use. The printout verified the laboratory was using reportable ranges that were wider -- 9 of 33 -- than the verified ranges: (a) BUN - 0-150 (b) Calcium - 5.0-15.0 (c) Creatinine - 0.15- 20.00 (d) Glucose - 0-500 (e) Chloride - 50-200 (f) CO2 - 5-45 (g) Potassium - 1-10 (h) Sodium - 50-200 (i) Albumin - 0.6-8.0 (j) ALT - 6-1000 (k) AST - 0-1000 (l) Alkaline Phosphatase - 10-1000 (m) Total Bilirubin - 0.1-25.0 (n) Total Protein - 2.0- 12.0 (4) The surveyor reviewed the findings with the clinical laboratory operations officer and laboratory supervisor. Both stated the laboratory was using the manufacturer's default reportable ranges for the above analytes, instead of the reportable ranges that had been demonstrated by the laboratory; (5) The following were examples of patient CMP testing performed when the laboratory was not using the verified reportable ranges: (a) Patient #254 - testing performed on 07/10/17 (b) Patient #255 - testing performed on 07/26/17 (c) Patient #256 - testing performed on 08/05/17 (d) Patient #257 - testing performed on 08/25/17 (e) Patient #258 - testing performed on 09/08/17 (f) Patient #259 - testing performed on 09/22/17 (g) Patient #260 - testing performed on 10/25/17 (h) Patient #261 - testing performed on 11/21/17 (i) Patient #262 - testing performed on 12/19/17 (j) Patient #263 - testing performed on 01/19/18 (k) Patient #264 - testing performed on 02/23/18 (l) Patient #265 - testing performed on 03/22/18 (m) Patient #266 - testing performed on 04/15/18 (n) Patient #267 - testing performed on 05/15/18 (o) Patient #268 - testing performed on 06/07/18 (p) Patient #269 - testing performed on 06/19/18 (q) Patient #270 - testing performed on 06/29/18 (r) Patient #271 - testing performed on 07/29/18 *CMP - BUN (Blood Urea Nitrogen), Calcium, Creatinine, Glucose, Chloride, CO2, Potassium, Sodium, Albumin, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Alkaline Phosphatase, Total Bilirubin, and Total Protein D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on a review of records, FDA database, information provided by the distributing manufacturer, correspondence with the CMS Central Office FDA liaison, and interview with the clinical laboratory operations officer and laboratory supervisor, the laboratory failed to establish the performance specifications of precision, reportable range, analytical sensitivity, analytical specificity, and reference intervals for an Erythrocyte Sedimentation Rate test system not cleared or approved by the FDA. Findings include: (1) On the first day of the survey, the clinical laboratory operations officer and laboratory supervisor stated to the surveyor ESR (Erythrocyte Sedimentation Rate) testing was performed using the Diesse Mini-Cube analyzer; (2) On the third day of the survey, the laboratory supervisor stated the laboratory began patient testing on 07/11/17; (3) The surveyor had not encountered this test system previously and therefore, attempted to verify the classification of the test. Since classification of test systems are performed by the FDA (Food and Drug -- 10 of 33 -- Administration), the surveyor reviewed the FDA test classification database. The database did not include a classification for the test kit (if a test is not included on the FDA site, then it did not go through the FDA approval process, which defaults the classification of the test as high complexity); (4) The surveyor explained this to the clinical laboratory operations officer and laboratory supervisor. The laboratory supervisor contacted the distributing manufacturer of the test system to obtain the FDA 510K approval. The distributing manufacturer responded with an email that stated, "In regards to the testing complexity, we do not have anything in writing stating the Diesse Mini-Cube is moderately complex, however, all automated ESR testing analyzers are considered moderately complex"; (5) The surveyor then contacted the CMS Dallas Regional Office, who in turn, contacted the CMS Central Office FDA liaison for confirmation of the classification of the test system. The surveyor was unable to find confirmation that the FDA had automatically classified all automated ESR test systems as moderate complexity, and therefore, determined the test system was classified as high complexity, which required the performance specifications of accuracy, precision, reportable range, analytical sensitivity, analytical specificity, and reference intervals (normal values) be established; (6) The surveyor reviewed the implementation records for the analyzer. There was no evidence the precision, reportable range, analytical sensitivity, analytical specificity, and reference intervals (normal values) had been established; (7) The surveyor reviewed the validation records with the clinical laboratory operations officer and laboratory supervisor. Both stated there were no records to prove the precision, reportable range, analytical sensitivity, analytical specificity, and reference intervals had been established; (8) Following the survey, on 08/03/18, the surveyor received an email from the CMS Central Office FDA liaison confirming that, if the test was not listed on the FDA CLIA database, then it was a high complexity test and the FDA had not automatically classified all automated ESR test systems as moderate complexity; (9) The following were examples of patient ESR testing performed: (a) Patient #212 - testing performed on 07/11/17 (b) Patient #213 - testing performed on 07/14/17 (c) Patient #214 - testing performed on 07/17/17 (d) Patient #215 - testing performed on 07/31/17 (e) Patient #216 - testing performed on 08/0/17 (f) Patient #217 - testing performed on 08/15/17 (g) Patient #218 - testing performed on 08/30/17 (h) Patient #219 - testing performed on 09/06/17 (i) Patient #220 - testing performed on 09/14/17 (j) Patient #221 - testing performed on 09/22/17 (k) Patient #222 - testing performed on 10/03/17 (l) Patient #223 - testing performed on 10/20/17 (m) Patient #224 - testing performed on 10/30/17 (n) Patient #225 - testing performed on 11/09/17 (o) Patient #226 - testing performed on 11/27/17 (p) Patient #227 - testing performed on 12/04/17 (q) Patient #228 - testing performed on 12/22/17 (r) Patient #229 - testing performed on 01/03/18 (s) Patient #230 - testing performed on 01/18/18 (t) Patient #231 - testing performed on 01/30/18 (u) Patient #232 - testing performed on 02/07/18 (v) Patient #233 - testing performed on 02/09/18 (w) Patient #234 - testing performed on 02/23/28 (x) Patient #235 - testing performed on 03/02/18 (y) Patient #236 - testing performed on 03/14/18 (z) Patient #237 - testing performed on 03/24/18 (aa) Patient #238 - testing performed on 04/02/18 (bb) Patient #239 - testing performed on 04/16 /18 (bb) Patient #240 - testing performed on 04/25/18 (cc) Patient #241 - testing performed on 05/09/18 (dd) Patient #242 - testing performed on 05/22/18 (ee) Patient #243 - testing performed on 06/04/18 (ff) Patient #244 - testing performed on 06/12 /18 (gg) Patient #245 - testing performed on 06/18/18 (hh) Patient #246 - testing performed on 06/29/18 (ii) Patient #247 - testing performed on 07/06/18 (jj) Patient #248 - testing performed on 07/0918 (kk) Patient #249 - testing performed on 07/10 /18 (ll) Patient #250 - testing performed on 07/12/18 (mm) Patient #83 - testing performed on 07/13/18 (nn) Patient #251 - testing performed on 07/14/18 (oo) Patient #252 - testing performed on 07/17/18 (pp) Patient #253 - testing performed on 07/18 -- 11 of 33 -- /18 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. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the clinical laboratory operations officer and laboratory supervisor, the laboratory failed to perform maintenance procedures as required by the manufacturer. Findings include: (1) On the first day of the survey, the clinical laboratory operations officer and laboratory supervisor stated to the surveyor CMP* (Comprehensive Metabolic Panel) testing was performed on the Siemens Dimension EXL 200 analyzer; (2) On the third day of the survey, the laboratory supervisor stated to the surveyor the laboratory began patient testing on 07/10/17; (3) The surveyor reviewed the manufacturer's maintenance instructions for the analyzer. One of the monthly maintenance requirements was to "Replace HM Pump Heads"; (4) Maintenance records were reviewed by the surveyor for 11 months (08/01/17 through 06/30/18). The Replace HM Pump Heads had not been documented as performed as follows: (a) Between 01 /28/18 and 03/13/18 (b) Between 04/24/18 and 07/03/18 (5) The surveyor reviewed the records with the clinical laboratory operations officer and laboratory supervisor. Both stated there was no evidence the maintenance had been performed as required; (6) The following were examples of patient testing performed: (a) Patient #264 - testing performed on 02/23/18 (b) Patient #267 - testing performed on 05/15/18 (c) Patient #268 - testing performed on 06/07/18 (d) Patient #269 - testing performed on 06/19/18 (e) Patient #270 - testing performed on 06/29/18 *CMP - BUN (Blood Urea Nitrogen), Calcium, Creatinine, Glucose, Chloride, CO2, Potassium, Sodium, Albumin, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Alkaline Phosphatase, Total Bilirubin, and Total Protein D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the clinical laboratory operations officer and laboratory supervisor, the laboratory failed to perform two levels of quality control materials each day of patient testing. Findings include: (1) On the first day of the survey, the clinical laboratory operations officer and laboratory supervisor stated to the surveyor Lactic Acid testing was performed using the EPOC test system; (2) On the second day of the survey, the laboratory supervisor stated the following to the surveyor: (a) The laboratory began performing patient testing on 07/10/17; (b) Two levels of quality control (QC) materials were performed with each new test kit -- 12 of 33 -- lot number and on a monthly basis; (c) Beginning in June 2018 (the laboratory supervisor began employment on 06/11/18), the laboratory began performing two levels of QC materials each day of patient testing. (3) The surveyor asked the laboratory supervisor if an IQCP (Individualized Quality Control Plan) had been developed for the test system prior to June 2018. The laboratory supervisor stated there was no documentation to prove an IQCP had not been developed. Therefore, the surveyor determined two levels of QC materials must be performed each day of patient testing; (4) The surveyor reviewed QC and patient testing records from 07/10 /17 through the second day of the survey. The review indicated two levels of QC materials had not been performed 15 of 22 days of patient testing reviewed; (5) The surveyor reviewed the records with the clinical laboratory operations officer and laboratory supervisor. Both stated two levels of QC materials had not been performed each day of patient testing; (6) The following were examples of patient Lactic Acid testing when two levels of QC materials had not been tested: (a) Patient #89 - testing performed on 07/15/17 (b) Patient #92 - testing performed on 07/18/17 (c) Patient #93 - testing performed on 07/20/17 and 06/03/18 (d) Patient #95 - testing performed on 08 /07/17 (e) Patient #96 - testing performed on 08/19/17 (f) Patient #97 - testing performed on 12/02/17 (g) Patient #99 - testing performed on 12/29/17 (h) Patient #100 - testing performed on 02/07/18 (i) Patient #101 - testing performed on 02/10/18 (j) Patient #105 - testing performed on 04/17/18 (k) Patient #107 - testing performed on 04/25/18 (l) Patient #109 - testing performed on 04/26/18 (m) Patient #111 - testing performed on 06/06/18 (n) Patient #112 - testing performed on 06/10/18 D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the clinical laboratory operations officer and laboratory supervisor, the laboratory failed to perform a negative and positive control each day of patient testing. Findings include: URINE DRUG SCREEN (1) On the first day of the survey, the clinical laboratory operations officer and laboratory supervisor stated to the surveyor Urine Drug Screen testing was performed using the MedTox Profile II ER test system; (2) Later on the first day, the laboratory supervisor stated to the surveyor the laboratory began performing patient testing on 01/06/18 (the laboratory supervisor did not begin employment until 06/11 /18). In addition, the laboratory supervisor stated to the surveyor negative and positive quality control (QC) materials were performed with each new test kit lot and on a weekly basis; (3) The surveyor asked the laboratory supervisor if an IQCP (Individualized Quality Control Plan) had been developed for the test system. The laboratory supervisor stated there was no documentation to prove an IQCP had not been developed. Therefore, the surveyor determined negative and positive QC testing must be performed each day of patient testing; (4) The surveyor reviewed QC and patient testing records from January 2018 through the first day of the survey. The review indicated n